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KEYTRUDA® (pembrolizumab)
Pivotal Phase 3 Data for KEYTRUDA® (pembrolizumab) in High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC) Published in the New England Journal of Medicine
February 9, 2022 5:00 pm ET
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the publication of results from the Phase 3 KEYNOTE-522 trial in the Feb. 10, 2022 edition of the New England Journal of Medicine. Results showed that neoadjuvant KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy followed by adjuvant KEYTRUDA as monotherapy (the KEYTRUDA regimen), significantly prolonged event-free survival (EFS) compared with neoadjuvant chemotherapy followed by adjuvant placebo (the chemotherapy-placebo regimen) in patients with high-risk early-stage triple-negative breast cancer (TNBC).
As previously reported, after a median follow-up of 39 months, the KEYTRUDA regimen reduced the risk of events or death by 37% (HR=0.63 [95% CI, 0.48-0.82]; p<0.001) versus the chemotherapy-placebo regimen. A total of 15.7% (n= 123/784) of patients who received the KEYTRUDA regimen had an EFS event compared to 23.8% (n= 93/390) of patients who received the chemotherapy-placebo regimen. The estimated three-year EFS rates were 84.5% (95% CI, 81.7-86.9) in the KEYTRUDA group compared with 76.8% (95% CI, 72.2-80.7) in the chemotherapy-placebo group. Event-free survival was defined as the time from randomization to the first occurrence of either disease progression that precluded definitive surgery, a local/distant recurrence, a second primary malignancy, or death from any cause. The safety profile of the KEYTRUDA regimen was consistent with the known profiles of each regimen, and no new safety concerns were identified. Additional detailed efficacy and safety data are also featured in the publication.
KEYTRUDA in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery is approved in the U.S. for the treatment of patients with high-risk early-stage TNBC. Additional global regulatory submissions are ongoing.
“These data, which supported the FDA approval and updates to the NCCN guidelines, establish that KEYTRUDA plus chemotherapy as neoadjuvant therapy followed by adjuvant KEYTRUDA could change clinical practice for the treatment of patients with high-risk early-stage TNBC,” said Dr. Peter Schmid, lead, Centre for Experimental Cancer Medicine, Barts Cancer Institute in London, England. “KEYNOTE-522 is the first prospective randomized Phase 3 trial to show an improvement in event-free survival among patients with stage II and stage III TNBC.”
“The study of KEYTRUDA in earlier disease states has long been a critical aspect of our clinical program,” Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We are incredibly proud that the New England Journal of Medicine has chosen to publish data from this pivotal neoadjuvant/adjuvant trial of KEYTRUDA in high-risk early-stage TNBC for the second time. Results from KEYNOTE-522, in which the KEYTRUDA regimen showed a significant 37% reduction in the risk of EFS events compared to neoadjuvant chemotherapy, represent an important advance and support earlier intervention with KEYTRUDA in these patients.”
Merck is rapidly advancing a broad portfolio in gynecologic and breast cancers with an extensive clinical development program for KEYTRUDA and several other investigational and approved medicines across these areas.
Study Design and Additional Data From KEYNOTE-522
KEYNOTE-522 is a Phase 3, randomized, double-blind trial (ClinicalTrials.gov, NCT03036488). The dual primary endpoints are pathological complete response (pCR), defined as pathological stage ypT0/Tis ypN0 at the time of definitive surgery, and EFS, defined as the time from randomization to the first occurrence of either disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause in all patients randomized. Secondary endpoints include pCR rate using alternative definitions, overall survival (OS) in all patients randomized, pCR rate according to all definitions, EFS and OS in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1), safety and health-related quality of life assessments. The study enrolled 1,174 patients who were randomized 2:1 to receive either:
- The KEYTRUDA regimen: KEYTRUDA (every three weeks) plus paclitaxel (weekly) and carboplatin (weekly or every three weeks) for four cycles, followed by KEYTRUDA plus cyclophosphamide and either doxorubicin or epirubicin (every three weeks) for four cycles as neoadjuvant therapy prior to surgery, followed by nine cycles of KEYTRUDA (every three weeks) as adjuvant therapy post-surgery (n=784); or
- The chemotherapy-placebo regimen: Placebo (every three weeks) plus paclitaxel (weekly) and carboplatin (weekly or every three weeks) for four cycles, followed by placebo plus cyclophosphamide and either doxorubicin or epirubicin (every three weeks) for four cycles as neoadjuvant therapy prior to surgery, followed by nine cycles of placebo (every three weeks) as adjuvant therapy post-surgery (n=390).
As previously announced, KEYNOTE-522 met the success criterion for the dual primary endpoint of pCR at the first interim analysis; pCR was observed in 64.8% of patients who received KEYTRUDA plus chemotherapy (n=260/401), an increase of 13.6% (p=0.00055) from 51.2% in patients who received placebo plus chemotherapy (n=103/201). At the fourth interim analysis, KEYNOTE-522 met the success criterion for the dual primary endpoint of EFS. The trial also evaluated OS, a key secondary endpoint. Although the OS data did not cross the boundary for statistical significance at the fourth interim analysis, there was a 28% reduction in the risk of death with the KEYTRUDA regimen versus the chemotherapy-placebo regimen (HR=0.72 [95% CI, 0.51-1.02]). The study is continuing to allow for additional follow-up of OS.
For the combined neoadjuvant and adjuvant phases, treatment-related adverse events Grade 3 or higher occurred in 77.1% of patients receiving the KEYTRUDA regimen (n=783) and in 73.3% of patients receiving the chemotherapy-placebo regimen (n=389). Treatment-related adverse events led to death in 0.5% of patients receiving the KEYTRUDA regimen (n=4) and 0.3% of patients receiving the chemotherapy-placebo regimen (n=1). No new safety concerns were identified.
Immune-mediated adverse events (AEs) of any grade occurred in 33.5% of patients receiving the KEYTRUDA regimen and 11.3% of patients receiving the chemotherapy-placebo regimen. A higher incidence of endocrine disorders was observed with the KEYTRUDA regimen as compared to the chemotherapy-placebo regimen. Immune-mediated AEs led to death in 0.3% of patients receiving the KEYTRUDA regimen (n=2) and no patients receiving the chemotherapy-placebo regimen. Most immune-mediated AEs occurred during the neoadjuvant phase rather than the adjuvant phase.
About KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,700 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma following complete resection.
Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:
- stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
Head and Neck Squamous Cell Cancer
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.
KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC):
- who are not eligible for any platinum-containing chemotherapy, or
- who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Non-muscle Invasive Bladder Cancer
KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Microsatellite Instability-High or Mismatch Repair Deficient Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
Gastric Cancer
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Esophageal Cancer
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
- in combination with platinum- and fluoropyrimidine-based chemotherapy, or
- as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.
Cervical Cancer
KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Tumor Mutational Burden-High Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
Cutaneous Squamous Cell Carcinoma
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.
Triple-Negative Breast Cancer
KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test.
For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf .
Source: Merck & Co., Inc.
Merck’s Keytruda combined with chemotherapy could benefit thousands of breast cancer patients
The combination significantly reduces cancer recurrence by approximately 37% and reduces secondary breast cancer by 39%
https://seekingalpha.com/symbol/MRK
Veklury® (Remdesivir)
February 11, 2022
Veklury® (Remdesivir) Retains Antiviral Activity Against Omicron, Delta and Other Emergent SARS-CoV-2 Variants in Multiple In Vitro Studies
-- Data Supports the Continued Use of Veklury for Treatment of COVID-19 for Current SARS-CoV-2 Variants --
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today released data demonstrating the in vitro activity of Veklury® (remdesivir) against ten SARS-CoV-2 variants, including Omicron. Results of Gilead studies are consistent with other in vitro studies independently conducted by researchers from institutions in other countries, including Belgium, Czech Republic, Germany, Poland, and the United States, which confirmed Veklury’s antiviral activity against multiple previously identified variants of SARS-CoV-2, including Alpha, Beta, Gamma, Delta and Omicron.
The study analyzed in vitro antiviral activity by two methods to understand the susceptibility of ten major SARS-CoV-2 variants to Veklury. The study results showed similar activity of Veklury against the variants and an early ancestral A lineage isolate detected in Seattle, WA (WA1 strain). Specifically, Delta and Omicron variants both remained fully susceptible to Veklury, and these laboratory results demonstrate that Veklury has remained active against all major variants isolated over the past two years.
Veklury directly inhibits viral replication inside host cells by targeting the SARS-CoV-2 RNA-dependent RNA polymerase. On entering the body, Veklury is transformed into the active triphosphate metabolite, which is then incorporated into the viral RNA and stops replication of the virus within the infected cells. The study analyzed nearly 6 million publicly available variant isolate sequences and confirmed that the nsp12 protein, the RNA polymerase target of Veklury, is highly conserved across all variants. Further characterization confirmed that none of the few identified nsp12 mutations prevalent in some of the SARS-CoV-2 variants affects the virus susceptibility to Veklury.
“These results provide evidence of the consistent and durable antiviral activity of remdesivir across known variants that have emerged throughout the pandemic, including Omicron and support its continued use for the treatment of COVID-19 for current SARS-CoV-2 variants,” said Tomas Cihlar, Senior Vice President of Virology Research, Gilead Sciences. “Now with a new version of Omicron (BA.2 subvariant) increasing in circulation around the world, these latest data also suggest that remdesivir will retain antiviral activity against this new subvariant because the viral RNA polymerase that remdesivir targets does not contain any additional unique mutations. Gilead continuously evaluates the activity of Veklury against viral variants.”
The results of this study have been submitted for publication in a peer-reviewed journal and have been uploaded as preprint at BioRxiv available here.
About Veklury
Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. At this time, more than half of patients hospitalized with COVID-19 in the United States are treated with Veklury. It can help reduce disease progression across a spectrum of disease severity and enable patients to recover faster, freeing up limited hospital resources and saving healthcare systems money.
Veklury was approved by the U.S. Food and Drug Administration (FDA) on October 22, 2020 for adults and pediatric patients 12 years of age and older and weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization. On January 21, 2022, the FDA approved a supplemental new drug application (sNDA) for Veklury to expand the indication to the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death. The expanded indication allows for Veklury to be administered in qualified outpatient settings that can administer daily intravenous (IV) infusions over three consecutive days. Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury.
Veklury is approved or authorized for temporary use in approximately 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 10 million patients around the world, including nearly 7 million people in 127 middle- and low-income countries through Gilead’s voluntary licensing program. These licenses currently remain royalty-free, reflecting Gilead’s existing commitment to enabling broad patient access to remdesivir.
U.S. Indication for Veklury
Veklury® (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, who are:
- Hospitalized, or
- Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
Veklury should only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. Veklury must be administered by intravenous infusion. Veklury is contraindicated in patients who are allergic to Veklury or any of its components. For more information, please see the U.S. full Prescribing Information available at www.gilead.com.
U.S. full Prescribing Information for Veklury is available at www.gilead.com.
Veklury, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220211005143/en/
Source: Gilead Sciences, Inc.
Gilead's remdesivir effective against multiple COVID variants, including Omicron
Feb. 11, 2022 8:46 AM ET
By: Jonathan Block, SA News Editor
- https://seekingalpha.com/news/3799155-gilead-remdesivir-effective-against-multiple-covid-variants-including-omicron
- https://seekingalpha.com/symbol/GILD
- https://www.vekluryhcp.com/
- https://www.gilead.com/
Vabysmo™ (faricimab) / Susvimo™ (previously called Port Delivery System with ranibizumab)
New two-year data for Roche’s Vabysmo and Susvimo reinforce potential to maintain vision with fewer treatments for people with two leading causes of vision loss
- In the YOSEMITE and RHINE studies in diabetic macular edema, at least 60% of eligible Vabysmo patients could extend treatment to every four months at two years, compared to 50% at year one
- Almost 80% of eligible Vabysmo patients could extend treatment to every three months or longer in both studies
- In the Archway study in neovascular age-related macular degeneration, 95% of Susvimo patients maintained a six-month treatment schedule at two years
Basel, 11 February 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new two-year data from its phase III studies of Vabysmo™ (faricimab) and Susvimo™ (previously called Port Delivery System with ranibizumab) will be presented at Angiogenesis, Exudation and Degeneration 2022 on 12 February. These longer-term results from the Vabysmo YOSEMITE and RHINE studies in diabetic macular edema (DME) and the Susvimo Archway study in neovascular or “wet” age-related macular degeneration (nAMD) further reinforce the potential to allow for longer time between treatments and fewer eye injections for people with these conditions, while still achieving and maintaining vision gains seen with previous standard-of-care injections. Neovascular AMD and DME are two leading causes of vision loss, together affecting around 40 million people worldwide, which require treatment with eye injections as often as once a month.1-4
“Results from these three studies reinforce the potential of Vabysmo and Susvimo to redefine standards of care and reduce treatment burden for people living with diabetic macular edema and neovascular AMD,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “These two first-of-their-kind treatments are the culmination of over a decade of pioneering research, aiming to better address the needs of people with retinal conditions.”
In the YOSEMITE and RHINE studies, at least 60% of people eligible for extended dosing with Vabysmo could be treated every four months at two years – a 10 percentage point increase since the primary analyses at one year – while achieving non-inferior vision gains versus aflibercept given every two months. Furthermore, nearly 80% of people eligible for extended dosing with Vabysmo could be treated every three months or longer. In the Archway study, Susvimo allowed 95% of people to go six months between treatments at two years – the fourth complete refill-exchange interval – while maintaining vision outcomes that were non-inferior to monthly ranibizumab injections. Across all three studies, with longer follow-up, Vabysmo and Susvimo continued to be generally well-tolerated, with favourable benefit-risk profiles. Safety will continue to be monitored closely in the post-market setting.
VabysmoTM (faricimab-svoa) is the first bispecific antibody for the eye approved by the U.S. Food and Drug Administration (FDA), and the only injectable eye medicine approved for treatments from one to four months apart in the first year following four initial monthly doses, based on evaluation of the patient’s anatomy and vision outcomes.5 Vabysmo is designed to block two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A are thought to contribute to vision loss by destabilising blood vessels, which may cause new leaky blood vessels to form and increase inflammation. While additional research continues, inhibition of both pathways has been shown in preclinical studies to have potentially complementary benefits, stabilising vessels and thereby reducing vessel leakage and inflammation more than inhibition of VEGF-A alone.4
Susvimo is the first nAMD treatment in 15 years to provide an alternative to standard-of-care eye injections. By continuously delivering medicine into the eye through a refillable implant, SusvimoTM (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant is the only FDA-approved treatment that may help people with nAMD maintain their vision with as few as two treatments per year.6
Vabysmo: YOSEMITE and RHINE Two-Year Results
In the YOSEMITE and RHINE studies, DME patients received Vabysmo, given either every two months or up to every four months using a treat and extend approach, or aflibercept given every two months. Two-year results showed Vabysmo patients maintained the vision improvements achieved in the first year and vision gains continued to be non-inferior to those achieved by aflibercept patients. In YOSEMITE, the average vision gains from baseline at two years were +10.7 eye chart letters in both the Vabysmo treat and extend and two-month arms, and +11.4 letters in the aflibercept arm. In RHINE, the average vision gains from baseline at two years were +10.1 and +10.9 letters in the Vabysmo treat and extend and two-month arms, respectively, and +9.4 letters in the aflibercept arm.
Importantly, 60% (n=162/270) of Vabysmo treat and extend patients in YOSEMITE and 64.5% (n=185/287) in RHINE achieved four-month dosing at two years. This is an increase over one-year results, which showed 52.8% (n=151/286) of Vabysmo treat and extend patients in YOSEMITE and 51% (n=157/308) in RHINE achieved four-month dosing. An additional 18.1% (n=49/270) of Vabysmo treat and extend patients in YOSEMITE and 13.6% (n=39/287) in RHINE achieved three-month dosing. Combined, almost 80% of Vabysmo treat and extend patients were able to go three months or longer between treatments at the end of the second year. Across study arms, Vabysmo showed consistent two-step or better improvement in diabetic retinopathy according to the Early Treatment Diabetic Retinopathy Study – Diabetic Retinopathy Severity Score (ETDRS-DRSS). At two years, 42.8% of Vabysmo treat and extend patients in YOSEMITE and 44.3% in RHINE achieved a two-step or better improvement from baseline. In the two-month Vabysmo arms, 51.4% and 53.5% of patients in YOSEMITE and RHINE, respectively, achieved a two-step or better improvement in diabetic retinopathy severity. Vabysmo given at intervals of up to four months continued to demonstrate greater reductions in central subfield thickness (CST) compared to aflibercept given every two months in both studies. Safety results were consistent across study arms, with no reported cases of retinal vasculitis or retinal occlusive events.
One-year results from the YOSEMITE and RHINE studies and the TENAYA and LUCERNE studies in nAMD were recently published in The Lancet.4,7
Susvimo: Archway Two-Year Results
Neovascular AMD patients in Archway received either Susvimo refilled every six months or monthly ranibizumab 0.5 mg eye injections. Two-year results showed vision was maintained by Susvimo patients and continued to be non-inferior to that achieved with monthly ranibizumab injections. Susvimo patients averaged -1.1 eye chart letters in visual acuity from baseline at two years, while monthly ranibizumab patients averaged -0.5 letters from baseline. In addition, 95% of Susvimo patients were able to go six months without needing additional treatment in the second, third and fourth refill-exchange intervals. In Archway, Susvimo was generally well-tolerated, with a favourable benefit-risk profile. The most common adverse events of special interest (≥5%) were cataract, conjunctival bleb and vitreous haemorrhage. The safety profile of Susvimo in the clinical trial setting is well understood and will continue to be monitored closely.
In addition to Archway results, two-year interim data from the ongoing phase III Portal study will be presented at the Angiogenesis meeting. Portal is an extension study evaluating the long-term safety and efficacy of Susvimo in nAMD.
Vabysmo is approved by the FDA for the treatment of nAMD and DME.5 Susvimo is approved by the FDA for the treatment of people with nAMD who have previously responded to at least two anti-VEGF injections.6 Vabysmo is currently under review by the European Medicines Agency for the treatment of nAMD and DME and Susvimo is under review for the treatment of nAMD. Submissions to other regulatory authorities around the world are ongoing.
Roche has a robust phase III clinical development programme for Vabysmo and Susvimo. For Vabysmo, the programme includes AVONELLE-X, an extension study of TENAYA and LUCERNE evaluating the long-term safety and tolerability of Vabysmo in nAMD, and RHONE-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in DME.8,9 Additionally, the COMINO and BALATON trials are also underway, evaluating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion.10,11
For Susvimo, the clinical development programme includes the Portal, Pagoda, Pavilion and Velodrome studies.12-15 Portal is an extension study evaluating the long-term safety and efficacy of Susvimo in nAMD.12 Pagoda is evaluating Susvimo for the treatment of DME, while Pavilion is a study of Susvimo in diabetic retinopathy without DME.13,14 Velodrome is evaluating Susvimo refilled every nine months in nAMD.15
About the YOSEMITE and RHINE studies7
YOSEMITE (NCT03622580) and RHINE (NCT03622593) are two identical, randomised, multicentre, double-masked, global phase III studies evaluating the efficacy and safety of Vabysmo™ (faricimab) compared to aflibercept in 1,891 people with diabetic macular edema (940 in YOSEMITE and 951 in RHINE). The studies each have three treatment arms: Vabysmo 6.0 mg administered up to every four months after four initial monthly doses using a treat and extend approach; Vabysmo 6.0 mg administered at two-month intervals after six initial monthly doses; and aflibercept administered at fixed two-month intervals after five initial monthly doses. Dosing schedule for patients within the treat-and-extend arm was determined by central subfield thickness (CST) and visual acuity. In all three arms, sham injections were administered at study visits when treatment injections were not scheduled to maintain the masking of investigators and participants.
The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline at one year, averaged over weeks 48, 52 and 56. Secondary endpoints include: safety; the percentage of participants in the treat and extend arm receiving Vabysmo every one, two, three and four months, at week 52; the percentage of participants achieving a two-step or greater improvement from baseline in diabetic retinopathy severity at week 52; the percentage of participants achieving a gain, and the percentage avoiding a loss, of 15 letters or more in BCVA from baseline over time; change in CST from baseline over time; and percentage of patients with absence of intraretinal fluid over time.
About the Archway study16
Archway (NCT03677934) was a randomised, multicentre, open-label phase III study evaluating the efficacy and safety of Susvimo™ (previously called Port Delivery System with ranibizumab), refilled every six months at fixed intervals, compared to monthly intravitreal injections of ranibizumab 0.5 mg in 415 people living with neovascular or “wet” age-related macular degeneration. Patients enrolled in Archway were responders to prior treatment with anti-vascular endothelial growth factor (VEGF) therapy. In both study arms, patients were treated with at least three anti-VEGF injections within the six months prior to their Archway screening visit. The primary endpoint of the study was the change in best-corrected visual acuity (BCVA) score from baseline at the average of Week 36 and Week 40. Secondary endpoints include safety, overall change in vision (BCVA) from baseline and change from baseline in centre point thickness over time.
About Vabysmo™ (faricimab)
Vabysmo™ (faricimab) is the first bispecific antibody designed for the eye. It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking both pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.4
About Susvimo™ (previously called Port Delivery System with ranibizumab)
Susvimo™ (previously called Port Delivery System with ranibizumab) is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure. Susvimo continuously delivers a customised formulation of ranibizumab over time. Susvimo is indicated for intravitreal use via the Susvimo eye implant only. Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.6
Susvimo is different from the ranibizumab intravitreal injection, a medicine marketed as Lucentis®* (ranibizumab injection), which is approved to treat nAMD and other retinal diseases. Lucentis* was first approved for nAMD by the FDA in 2006.24
For more information, please visit www.roche.com.
Roche's Vabysmo, Susvimo helps maintain vision with fewer treatments in phase 3 studies
Feb. 11, 2022 6:43 AM ET
Roche Holding AG (RHHBY), RHHBF
By: Ravikash, SA News Editor
Roche's (OTCQX:RHHBY) (OTCQX:RHHBF) unit Genentech reported positive two-year data from its phase 3 studies of Vabysmo (faricimab-svoa) and Susvimo (ranibizumab injection).
https://seekingalpha.com/symbol/RHHBY
https://seekingalpha.com/symbol/RHHBF
https://www.gene.com/patients/medicines/vabysmo
https://www.gene.com/patients/medicines/susvimo
VENCLEXTA® (venetoclax) in Combination with Azacitidine
AbbVie Announces First Provincial Reimbursements for VENCLEXTA® (venetoclax) in Combination with Azacitidine for Acute Myeloid Leukemia (AML) Patients
Feb. 10, 2022 7:00 AM ET AbbVie Inc. (ABBV)
- Following the signing of an agreement between AbbVie and the pan-Canadian Pharmaceutical Alliance (pCPA), Quebec, Saskatchewan, and Manitoba are the first provinces to reimburse the combination treatment for newly diagnosed acute myeloid leukemia (AML) patients who are ineligible for intensive induction chemotherapy.
MONTREAL, Feb. 10, 2022 /CNW/ - AbbVie (ABBV), a research-based global biopharmaceutical company, announced today that an agreement was reached with the pan-Canadian Pharmaceutical Alliance (pCPA) for VENCLEXTA® (venetoclax) in combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.i Effective February 2nd, on Québec's Liste des medicaments-établissements, effective February 1st on Saskatchewan Cancer Agency drug formulary, and effective February 24th on Manitoba's Drug Benefits and Interchangeability Formulary, VENCLEXTA is listed in combination with azacitidine, for first line treatment of patients with newly diagnosed AML who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. For full criteria, consult the list of medications in effect.ii, iii, iv"Acute myeloid leukemia is a blood cancer with a survival rate that still needs to be improved. Intensive chemotherapy treatments lead to toxicity, which can limit their use. However, our understanding of this disease has improved considerably over the past few years and, thanks to new treatment options such as the combination of venetoclax and azacitidine, we are now able to effectively treat a greater proportion of patients," explains Dr. Julie Bergeron, MD, FRCPC, associate clinical professor, head of the Optilab CHUM cluster of hematology laboratories, and hematologist at the CEMTL Maisonneuve-Rosemont facility.In Canada, the five-year net survival rate is approximately 21% for people diagnosed with AML in the general population. v"Every day, we aim to transform the standard of care in Oncology. Having effective and proven treatment options is vital for patients and their families impacted by AML. It is great news that VENCLEXTA plus azacitidine is now reimbursed in Quebec, Saskatchewan and Manitoba for people living with AML," says Tracey Ramsay, Vice President and General Manager, AbbVie Canada.VENCLEXTA in combination with azacitidine was approved by Health Canada in December 2020. Health Canada's approval was granted under Project Orbis, an FDA initiative which provides a framework for concurrent submission and accelerated review of oncology products among international partners.VENCLEXTA is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
For more information about AbbVie, please visit us at www.abbvie.ca. Follow @abbviecanada on Twitter or find us on LinkedIn. SOURCE AbbVie Canada
https://seekingalpha.com/symbol/ABBV
Azacitidine
(ay-za-SYE-ti-deen)
Trade Name(s): Vidaza®, Onureg®
Other Name(s): 5-azacitadine
https://chemocare.com/chemotherapy/drug-info/Vidaza.aspx
Uses
VENCLEXTA is a prescription medicine used:
- to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly diagnosed acute myeloid leukemia (AML) who:
- are 75 years of age or older, or
- have other medical conditions that prevent the use of standard chemotherapy.
It is not known if VENCLEXTA is safe and effective in children.
Sotrovimab
Data Suggest Sotrovimab Retains Neutralizing Activity Against Omicron Subvariant BA.2
02/10/22 at 1:24 AM ESTPDF Version
– Pseudovirus results being shared with government and regulatory authorities;
publication in bioRxiv anticipated in the coming week; additional live virus testing underway –
SAN FRANCISCO, Feb. 09, 2022 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that preclinical data suggest that sotrovimab, an investigational monoclonal antibody authorized for emergency use in the United States and developed in conjunction with GlaxoSmithKline, retains neutralizing activity against the BA.2 subvariant of Omicron. These pseudovirus results are being shared with government and regulatory authorities around the world and the Company expects to publish data on bioRxiv in the coming week, with live virus data to follow.
“Our view of the data is that they support the ongoing role of sotrovimab as a critical treatment in the fight against the continuously evolving SARS-CoV-2 virus,” said George Scangos, Vir’s chief executive officer. “We note recent conclusions from another lab, which state that no approved or authorized monoclonal antibodies for treatment retain activity against all subvariants of Omicron. We are therefore pleased to share that, based on our pseudovirus and extensive pharmacokinetic data, we believe that the 500 mg dose of sotrovimab is sufficient to retain activity against the BA.2 variant, just as it has against all other variants of concern and interest.”
About sotrovimab
Sotrovimab is an investigational SARS-CoV-2 neutralizing monoclonal antibody. The antibody binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor, Inc.’s Xtend™ technology, has also been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.
About global access to sotrovimab
Sotrovimab is authorized for emergency use in the US and has been granted a marketing authorization in the European Union (EU), conditional marketing authorization in Great Britain, provisional marketing authorization in Australia, and conditional marketing authorization in Saudi Arabia. It has also been approved via Japan’s Special Approval for Emergency Pathway. Temporary authorizations for sotrovimab have also been granted in 12 other countries.
Sotrovimab is supplied in several countries worldwide, including through national agreements in the US, UK, Japan, Australia, Canada, Singapore, Switzerland, and the United Arab Emirates. Vir and GlaxoSmithKline are also supplying sotrovimab to participating Member States of the EU through a Joint Procurement Agreement with the European Commission. Additional agreements are yet to be disclosed due to confidentiality or regulatory requirements.
Sotrovimab in the United States
The following is a summary of information for sotrovimab. Healthcare providers in the US should review the Fact Sheets for information about the authorized use of sotrovimab and mandatory requirements of the Emergency Use Authorization (EUA). Please see the Food and Drug Administration (FDA) Letter of Authorization, full Fact Sheet for Healthcare Providers and full Fact Sheet for Patients, Parents, and Caregivers.
Sotrovimab has been authorized by the US FDA for the emergency use described below. Sotrovimab is not FDA-approved for this use.
Sotrovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab under section 564(b)(1) of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Authorized use
The FDA has issued an EUA to permit the emergency use of the unapproved product sotrovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Limitations of authorized use
Sotrovimab is not authorized for use in patients:
- who are hospitalized due to COVID-19, OR
- who require oxygen therapy due to COVID-19, OR
- who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity)
Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID-19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID19 requiring high flow oxygen or mechanical ventilation.
Important Safety Information
CONTRAINDICATIONS
Sotrovimab is contraindicated in patients who have a history of anaphylaxis to sotrovimab or to any of the excipients in the formulation.
We routinely post information that may be important to investors on our website at www.vir.bio.
Source: Vir Biotechnology, Inc.
GSK-Vir's COVID therapy retains neutralizing activity against Omicron variant
Feb. 10, 2022 5:28 AM ET Vir Biotechnology, Inc. (VIR), GSK By: Ravikash, SA News Editor
- GlaxoSmithKline (NYSE:GSK) Vir Biotechnology (NASDAQ:VIR) said preclinical data suggested that their COVID-19 therapy sotrovimab retained neutralizing activity against the BA.2 subvariant of Omicron.
- https://seekingalpha.com/news/3798381-gsk-virs-covid-therapy-retains-neutralizing-activity-against-omicron-variant
- https://seekingalpha.com/symbol/GSK
- https://seekingalpha.com/symbol/VIR
- https://www.sotrovimab.com/
February 8, 2022
FDA Approves JUVÉDERM® VOLBELLA® XC For Undereye Hollows
JUVÉDERM® VOLBELLA® XC, PART OF THE NUMBER ONE CHOSEN COLLECTION OF FILLERS, IS THE FIRST AND ONLY DERMAL FILLER TO RECEIVE FDA APPROVAL FOR THE IMPROVEMENT OF INFRAORBITAL HOLLOWS[1,2]
IRVINE, Calif., Feb. 8, 2022 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announces the FDA approval of JUVÉDERM® VOLBELLA® XC for improvement of infraorbital hollows in adults over the age of 21.2 According to clinical trial data, 90% of subjects reported satisfaction through one year after treatment.2 With this approval, Allergan Aesthetics continues the expansion of its treatment portfolio to better address unmet patient needs. Per FDA requirement for this new indication, Allergan Aesthetics is providing a product training program for all interested providers, which includes facial anatomy and considerations for safe injection in this area, as well as identification and management of potential complications. Successful completion of this training is necessary prior to administration of JUVÉDERM® VOLBELLA® XC for this new indication.
"This additional indication for JUVÉDERM® VOLBELLA® XC demonstrates Allergan Aesthetics' continued commitment to innovation. The eye area, including the undereye hollow, is a top concern among patients," says Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "Allergan Aesthetics offers the broadest portfolio of treatment options designed to address the delicate eye area from topical skin care with SkinMedica®, to crow's feet lines with BOTOX® Cosmetic (onabotulinumtoxinA) and now, with this approval, the infraorbital hollows, commonly referred to as tear troughs, with JUVÉDERM® VOLBELLA® XC."
Patient safety and consumer satisfaction are a top priority at Allergan Aesthetics. As the JUVÉDERM® Collection of Fillers continues to be at the forefront of innovation, Allergan Aesthetics is committed to providing best-in-class training to our providers through the Allergan Medical Institute (AMI). During the required infraorbital hollows training, providers will be educated on how to assess facial anatomy holistically where JUVÉDERM® VOLUMA® XC may be added as part of a treatment plan to address volume loss in the midface. The safety and efficacy of combined use of JUVÉDERM® VOLUMA® XC and JUVÉDERM® VOLBELLA® XC has not been studied. The required training can be accessed and completed at VolbellaTraining.com.
"The undereye area is one of the most frequently requested treatment sites among patients, regardless of race and ethnicity, but it is undertreated.3 This is in part because it is a sensitive area to inject as it takes great skill and precision," says AMI trainer, Board Certified Oculofacial Plastic Surgeon and Ophthalmologist, Dr. Julie Woodward. "The approval of JUVÉDERM® VOLBELLA® XC is a milestone in offering providers, like myself, a safe and effective treatment option to address the undereye area for my patients. The characteristics of JUVÉDERM® VOLBELLA® XC with lower amounts of hyaluronic acid molecules and low water affinity provides a soft, smooth formulation appropriate for treating undereye hollows and I am excited to work with Allergan Aesthetics on a robust injector and patient education plan to ensure safe and effective outcomes in this challenging to treat area. The results of the clinical trial demonstrate significant improvements in the appearance of undereye hollows and overall appearance. In addition, 80% of subjects reported they were a little or not at all bothered by how tired and old the under-eye area looked at 3 months compared to 15% and 30% before treatment, respectively.2"
According to the clinical studies, the primary effectiveness criteria were met in the treatment group's responder rate of 83.1% and was statistically significantly greater (p<0.0001) than the responder rate for the no–treatment control group (15.6%) based on the mITT population with multiple imputation. The mean improvement was clinically significant (≥ 1 point), with the majority of subjects demonstrating improvement through one year.5 In addition, 90.1% of patients were willing to recommend the treatment to a friend.5
Consumers and new patients who receive aesthetic treatment from the JUVÉDERM® Collection of Fillers, can also enroll in Allē, Allergan Aesthetics loyalty rewards program to unlock access to curated content, exclusive offers, and personalized rewards that can be used for savings on the Allergan Aesthetics portfolio of products and redeemed at a participating provider's office, subject to program terms and conditions that apply. Allē is the first and only loyalty program in the aesthetics market to also offer consumers the ability to earn points on over 40 non-Allergan Aesthetics treatments and brands.
The majority of subjects in the clinical study experienced a side effect, such as tenderness to touch, bruising, swelling, lumps/bumps, redness, pain after injection, firmness, discoloration (not redness or swelling), or itching as reported in their 30-day daily diaries. A majority of these side effects were mild (easily tolerated) in severity, although a few subjects experienced mild swelling more than 30 days after treatment. The swelling was treated with antibiotics for 1 subject; the other subjects did not require treatment. All of these events resolved within 45 days.4
JUVÉDERM® VOLBELLA® XC was first FDA–approved in 2016 for use in the lips and perioral rhytids.2 As the category leader, the JUVÉDERM® Collection of Fillers offers the broadest portfolio of specifically tailored treatment options, and this latest approval marks the sixth approved indication in the U.S.
For more information on the JUVÉDERM® Collection of Fillers, visit Juvéderm.com and follow @JUVÉDERM on Instagram.
For more information about AbbVie, please visit us at www.abbvie.com.
INDICATIONS
JUVÉDERM® VOLUMA® XC injectable gel is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21.
JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.
JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
JUVÉDERM® Ultra XC injectable gel is also indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
AbbVie's JUVÉDERM VOLBELLA gets FDA nod for expanded use for undereye hollows
Feb. 08, 2022 8:32 AM ET AbbVie Inc. (ABBV)
By: Ravikash, SA News Editor3 Comments
- The U.S. FDA approved the expanded use of AbbVie's (NYSE:ABBV) medicine JUVÉDERM VOLBELLA XC for improvement of infraorbital hollows in adults over the age of 21.The company said that according to trial data, 90% of people reported satisfaction through one year after treatment.
- https://seekingalpha.com/news/3797157-abbvies-juvderm-volbella-gets-fda-nod-for-expanded-use-for-undereye-hollows
- https://seekingalpha.com/symbol/ABBV
- https://www.abbvie.com/
- https://www.juvederm.com/treatment/juvederm-ultra-xc
ADCETRIS (brentuximab vedotin) in combination with chemotherapy
ADCETRIS® Combination Significantly Improves Overall Survival in Newly Diagnosed Patients with Advanced Hodgkin Lymphoma
02/03/2022
– Full Data from Phase 3 ECHELON-1 Clinical Trial to be Submitted for Presentation at Upcoming Medical Meeting –
BOTHELL, Wash.--(BUSINESS WIRE)-- Seagen Inc. (Nasdaq:SGEN) today announced that the phase 3 ECHELON-1 clinical trial demonstrated a statistically significant improvement in overall survival (OS) (p=0.009) in patients with advanced classical Hodgkin lymphoma (cHL) following treatment with ADCETRIS (brentuximab vedotin) in combination with chemotherapy. With approximately six years median follow up, patients receiving ADCETRIS plus doxorubicin, vinblastine, and dacarbazine (A+AVD) in the frontline setting had a 41 percent reduction in the risk of death (HR 0.59; [95% CI: 0.396 to 0.879]) compared with patients receiving doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). The safety profile of ADCETRIS was consistent with previous studies and no new safety signals were observed.
“These groundbreaking results are important for patients with advanced classical Hodgkin lymphoma given that an improvement in overall survival has rarely been shown in frontline treatment of this disease,” said Roger Dansey, M.D., Chief Medical Officer at Seagen. “We look forward to presentation of the results at an upcoming medical meeting.”
ECHELON-1 is an open-label, international, randomized, phase 3 trial evaluating the safety and efficacy of frontline ADCETRIS plus AVD versus ABVD in 1,334 adult patients with stage III or IV cHL. Patients were randomly assigned to receive A+AVD or ABVD intravenously on days 1 and 15 of each 28-day cycle for up to six cycles. OS is the key secondary endpoint of the trial. The primary endpoint, modified progression free survival, served as the basis for global regulatory approvals.
Please see Important Safety Information, including BOXED WARNING, for ADCETRIS below.
ADCETRIS is approved for certain types of relapsed or refractory Hodgkin lymphoma (HL) including previously untreated Stage III/IV cHL and previously untreated peripheral T-cell lymphoma (PTCL). It has received marketing authorization in more than 75 countries and is being evaluated globally in more than 70 corporate- and investigator-sponsored clinical trials across multiple settings in lymphoma and other diseases.
About ADCETRIS
ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seagen’s proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing cells.
ADCETRIS is indicated for the treatment of adult patients with:
- previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine,
- cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation,
- cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates,
- previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone,
- sALCL after failure of at least one prior multi-agent chemotherapy regimen, and
- primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides who have received prior systemic therapy.
Seagen and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seagen has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seagen and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.
For more information on the company’s marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.
1 https://www.cancer.org/cancer/hodgkin-lymphoma.html
View source version on businesswire.com: https://www.businesswire.com/news/home/20220203005330/en/
Source: Seagen Inc.
Seagen's Adcetris combo improves survival of blood cancer patients in phase 3 trial
Feb. 03, 2022 12:50 PM ET Seagen Inc. (SGEN) By: Ravikash, SA News Editor
- Seagen (SGEN -1.1%) said its medicine Adcetris (brentuximab vedotin) in combination with chemotherapy showed statistically significant improvement in overall survival in patients with advanced classical Hodgkin lymphoma (cHL) in a phase 3 trial, dubbed ECHELON-1.
- https://seekingalpha.com/news/3795661-seagens-adcetris-combo-improves-survival-of-blood-cancer-patients-in-phase-3-trial
- https://seekingalpha.com/symbol/SGEN
- https://www.adcetris.com/
- https://www.seagen.com/
Dexcom G6 Continuous Glucose Monitoring System
Dexcom G6 Continuous Glucose Monitoring System Now Covered in Alberta for Children and Youth Living With Diabetes
- Dexcom CGM use is proven to improve glycemic control1,2and can reduce the risk of costly diabetes-related complications compared to fingerstick monitoring.3
The Dexcom G6 CGM System is now covered by Alberta Health for people with diabetes who are under 18 years old and require ongoing use of insulin or insulin pump therapy (Photo: Business Wire)
February 03, 2022 05:19 PM Eastern Standard Time
BURNABY, British Columbia--(BUSINESS WIRE)--Dexcom, Inc. (NASDAQ: DXCM), the global leader in real-time continuous glucose monitoring (CGM), announced today that people with diabetes who are under 18 years old and require ongoing use of insulin or insulin pump therapy are eligible for public coverage of the Dexcom G6 CGM System through Alberta Health.
“Today’s announcement means more pediatric patients will have access to this life-changing technology to manage their diabetes.”
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Alberta joins five other jurisdictions in providing public coverage of real-time CGM systems under provincial health plans. The Non-Insured Health Benefits Program also recently announced coverage for First Nations and Inuit children. With expanded public coverage for CGM, more children and youth can access this standard of care technology, helping them manage their diabetes.
For more information about Dexcom CGM, visit www.dexcom.com.
Dexcom's G6 continuous glucose monitoring system gets coverage in Alberta
Feb. 03, 2022 5:27 PM ET DexCom, Inc. (DXCM)
By: Ravikash, SA News Editor
- Dexcom (NASDAQ:DXCM) said people with diabetes who are under 18 years of age and require ongoing use of insulin or insulin pump therapy are eligible for public coverage of Dexcom G6 CGM System through Alberta Health.
- https://seekingalpha.com/news/3795877-dexcoms-g6-continuous-glucose-monitoring-system-gets-coverage-in-alberta
- https://seekingalpha.com/symbol/DXCM
- https://www.dexcom.com/
- https://www.dexcom.com/g6-cgm-system
Spikevax (previously COVID-19 Vaccine Moderna)
MODERNA RECEIVES FULL U.S. FDA APPROVAL FOR COVID-19 VACCINE SPIKEVAX
JANUARY, 31, 2022 DOWNLOAD(OPENS IN NEW WINDOW)
Approval based on a comprehensive submission package including efficacy and safety data approximately six months after second dose
SPIKEVAX has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel
807 million doses of Moderna's COVID-19 vaccine shipped globally in 2021; approximately 25% of those doses shipped to low- and middle-income countries
CAMBRIDGE, MA / ACCESSWIRE / January 31, 2022 / Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older.
"Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death. The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S.," said Stéphane Bancel, Chief Executive Officer of Moderna. "The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved. We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic."
The FDA based its decision on the totality of scientific evidence shared by the Company in its submission package, which included follow-up data from the Phase 3 COVE study showing high efficacy and favorable safety approximately six months after the second dose. Moderna also submitted manufacturing and facilities data required by the FDA for licensure. SPIKEVAX has received approval by regulators in more than 70 countries.
Moderna's COVID-19 vaccine was available under Emergency Use Authorization (EUA) in the U.S. from December 18, 2020. Under an EUA, the FDA has the authority to allow medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions during a declared public health emergency when there are no adequate, approved, and available alternatives. A booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level is authorized for emergency use in the U.S. under EUA for adults 18 years and older. A third dose of the Moderna COVID-19 vaccine at the 100 µg dose level is authorized for emergency use in immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
INDICATION (U.S.)
SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
To learn more, visit www.modernatx.com.
SOURCE: Moderna, Inc.
View source version on accesswire.com:
https://www.accesswire.com/686397/Moderna-Receives-Full-US-FDA-Approval-for-COVID-19-Vaccine-Spikevax
Moderna granted full FDA approval for COVID-19 vaccine
Jan. 31, 2022 11:21 AM ET Moderna, Inc. (MRNA)PFE, BNTX
By: Dulan Lokuwithana, SA News Editor4 Comments
- Moderna (MRNA +2.7%) shares are trading higher after announcing that the FDA approved its Biologics License Application (BLA) for its COVID-19 vaccine. With full approval, the messenger-RNA-based shot is allowed for use under the brand name SPIKEVAX for COVID-19 prevention in those aged 18 years and above.
- https://seekingalpha.com/news/3793583-moderna-granted-full-fda-approval-for-covid-19-vaccine
- https://seekingalpha.com/symbol/MRNA
- https://www.modernatx.com/
MODERNA RECEIVES FULL U.S. FDA APPROVAL FOR COVID-19 VACCINE SPIKEVAX
JANUARY 31, 2022 DOWNLOAD(OPENS IN NEW WINDOW)
Approval based on a comprehensive submission package including efficacy and safety data approximately six months after second doseSPIKEVAX has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel807 million doses of Moderna's COVID-19 vaccine shipped globally in 2021; approximately 25% of those doses shipped to low- and middle-income countriesCAMBRIDGE, MA / ACCESSWIRE / January 31, 2022 / Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older.https://investors.modernatx.com/news/news-details/2022/Moderna-Receives-Full-U.S.-FDA-Approval-for-COVID-19-Vaccine-Spikevax/default.aspxhttps://seekingalpha.com/symbol/MRNA
Hugo™ robotic-assisted surgery system
FEB 2, 2022
Medtronic announces first procedure in Europe with Hugo™ robotic-assisted surgery system
Robotic prostatectomy performed by Doctor Alexandre Mottrie at Onze-Lieve-Vrouw Ziekenhuis (OLV) in Aalst, Belgium
DUBLIN and AALST, Belgium, Feb. 2, 2022 /PRNewswire(opens new window)/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, and OLV Hospital Aalst today announced that the first clinical procedure in Europe was performed with the Hugo™ robotic-assisted surgery (RAS) system. The robotic prostatectomy was performed by Prof. Alexandre Mottrie, M.D., head of urology at OLV Hospital in Aalst, Belgium, and chief executive officer and founder of the Belgium-based ORSI Academy, a multidisciplinary center for training, research and development, and data analysis to improve minimally invasive surgery best practices.
View File Download FileMedtronic-Surgical-Robotics
"Performing Europe's very first procedure with the Hugo RAS system is a career highlight for me," said Dr. Mottrie. "With more than two decades and 4,000 robotic-assisted surgery procedures under my belt, I am intimately aware of the barriers that have kept the benefits of surgical robotics from physicians, hospitals, and patients. Now, I believe we are entering a new era filled with greater access and flexibility."
A form of minimally invasive surgery, robotic-assisted surgery offers fewer complications, shorter hospital stays, faster return to normal activities, and smaller scars than open surgery.1–3,†
"This is an exciting and important moment for healthcare in Europe and we're proud to share it with Dr. Mottrie and the team at OLV," said Megan Rosengarten, president of the Surgical Robotics business, which is part of the Medical Surgical Portfolio at Medtronic. "Dr. Mottrie has left a meaningful mark on our program over the many years we've worked together, and now, through our partnership with OLV, Medtronic's journey to bring the benefits of robotic-assisted surgery to more patients in Europe is well underway."
The Hugo RAS system — Medtronic's solution to historic cost and utilization barriers that have kept surgical robotics out of reach for many hospitals — is a modular, multi-quadrant platform designed for a broad range of soft-tissue procedures. It combines wristed instruments, 3D visualization, and Touch Surgery™ Enterprise, a cloud-based surgical video capture and management solution, with dedicated support teams specializing in robotics program optimization, service, and training.
In 2021, Medtronic announced the first urologic and gynecologic procedures with the Hugo system in Latin America and Asia-Pacific. Those procedures and cases in Europe will become part of the Hugo RAS system patient registry, which is collecting clinical data to support regulatory submissions around the world.
"The Hugo RAS system introduces the long-awaited power of choice in the category and will redefine all that robotic-assisted surgery can make possible," said Henk Westendorp, senior country director Benelux at Medtronic. "Medtronic thoughtfully designed the Hugo RAS system with surgeons in mind and patients at heart to tackle today's barriers to adoption in a future-proofed way. We know that by innovating real solutions for the way surgeons want to work — alongside partners like OLV Hospital Aalst who share our passion for advancing patient care — we can make a substantial impact."
"We're incredibly proud to have left our stamp on medical history as the very first center in the region to embrace surgical robotics in 1999," said Peter Verhulst, chief executive officer, OLV Hospital Aalst. "Decades later, we are delighted to be recognized as a robotic surgery center of excellence, leaving another indelible mark as the first hospital in all of Europe to offer the Hugo RAS system and the first in the world to have Medtronic's two RAS platforms — the Hugo system for soft tissue and the Mazor™ system for spinal surgery. The OLV Hospital closely monitors innovation in the medical world and often plays a pioneering role in the introduction of new minimally invasive techniques. The worldwide reputation of our OLV doctors in the field of robotic surgery and other minimally invasive procedures is a result of this. With the Hugo RAS system, we are again at the forefront, with the latest medical innovation that is designed with the patient at heart."
The Hugo RAS system is commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. In the EU, the Hugo RAS system is CE marked. In Canada, the Hugo RAS system has a medical device licence. The Hugo RAS system is approved in Australia. In the U.S., the Hugo RAS system is an investigational device not for sale. Touch Surgery Enterprise is not intended to direct surgery, or aid in diagnosis or treatment of a disease or condition.
For more information, visit medtronic.com/hugo(opens new window).
About OLV Hospital in Aalst, Belgium
The OLV Hospital offers a wide range of medical consultations, examinations, interventions, treatments and aftercare - both in the outpatient center and inpatient setting - at the campus in Aalst, the branch in Asse and the medical centre in Ninove. OLV Hospital always strives to limit the impact of an intervention on the patient as much as possible so that a quicker recovery is possible. As a result, OLV Hospital is also a pioneer in the field of minimally invasive techniques and precision surgery with the support of the operating robot. The physicians and staff at OLV Hospital do everything possible to provide Top in Care. Besides the physical health of patients, they also want to look after their well-being in all its aspects and in every stage of life.
With 2,554 employees and more than 300 doctors and independent care professionals, OLV Hospital is the largest employer in the region, and with 959 beds (114 of which in outpatient care) and more than 90,000 admissions (hospitalisation and outpatient care) per year, OLV Hospital is one of the largest non-university hospitals in Flanders.
For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com(opens new window) and follow @Medtronic(opens new window) on Twitter and LinkedIn(opens new window).
Medtronic reports 1st procedure in Europe with Hugo robotic-assisted surgery system
Feb. 02, 2022 8:18 AM ET Medtronic plc (MDT) By: Ravikash, SA News Editor
- Medtronic (NYSE:MDT) said the first clinical procedure in Europe with the Hugo robotic-assisted surgery (RAS) system was performed.
- https://seekingalpha.com/news/3794812-medtronic-reports-1st-procedure-in-europe-with-hugo-robotic-assisted-surgery-system
- https://seekingalpha.com/symbol/MDT
- https://www.medtronic.com/covidien/en-us/robotic-assisted-surgery/hugo-ras-system.html?sfdcid=7014O000001JF3G&cid=PPC:BING:%2Bhugo%20%2Brobotic%20%2Bassisted%20%2Bsurgery:ras-hugo
- https://www.medtronic.com/covidien/en-us/index.html
Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Jazz Pharmaceuticals Completes U.S. FDA Supplemental Biologics License Application for Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) Monday/Wednesday/Friday Dosing Schedule
February 02, 2022Download PDFPhase 2/3 trial data, the basis for submission, demonstrates Rylaze maintains a clinically meaningful level of nadir serum asparaginase activity throughout the entire duration of treatment for adult and pediatric patients with acute lymphoblastic leukemia and lymphoblastic lymphoma
Submission will be reviewed under FDA's Real-Time Oncology Review Program
DUBLIN, Feb. 2, 2022 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company has completed the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for a Monday/Wednesday/Friday (M/W/F) intramuscular (IM) dosing schedule for Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn), for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month and older who have developed hypersensitivity to E. coli-derived asparaginase. The submission will be reviewed under the Real-Time Oncology Review (RTOR) program, an initiative of FDA's Oncology Center of Excellence designed for efficient review of safe and effective cancer treatments, and follows Rylaze's initial approval under the RTOR program in June 2021.
"We were pleased Rylaze, a much-needed therapeutic option, was approved under the RTOR program while the clinical trial was ongoing. Our science-led and patient-focused development program has enabled us to deliver a clinically significant advancement for patients," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals. "With a dosing schedule of Rylaze administered 25/25/50 mg/m2 on Monday/Wednesday/Friday, patients maintain a clinically meaningful level of nadir serum asparaginase activity through the entire duration of treatment. We look forward to submitting two additional regulatory applications this year to ensure as many patients as possible can have access to a reliable and high-quality supply of this important therapy, including another regulatory application to FDA to support the intravenous route of administration and an additional application in Europe later this year."
The sBLA submitted by Jazz is supported by data from the three-cohort intramuscular administration part of the Phase 2/3 trial of Rylaze in adult and pediatric patients with ALL and LBL who have developed hypersensitivity to an E. coli-derived asparaginase. The trial studied three dosing regimens of Rylaze, with cohort 1a receiving 25 mg/m2 administered M/W/F, cohort 1b receiving 37.5 mg/m2 administered M/W/F and cohort 1c receiving 25 mg/m2 administered Monday and Wednesday and 50 mg/m2 administered on Friday. Initial results showed that in cohort 1c, a dosing regimen of Rylaze administered 25 mg/m2 on Monday and Wednesday and 50 mg/m2 on Friday demonstrated a positive benefit-to-risk profile, showing that Rylaze maintains a clinically meaningful level of nadir serum asparaginase activity (NSAA) ≥0.1 IU/mL at both 48 and 72 hours (from Friday to Monday). In addition, the safety profile of Rylaze was consistent with the reported safety information for patients with ALL/LBL receiving asparaginase with combination chemotherapy. Initial results from the trial were presented at the 63rd American Society of Hematology (ASH) Annual Meeting in December 2021.1
The sBLA follows FDA approval of Rylaze in June 2021 under the RTOR program.2 Rylaze was also granted orphan drug designation for the treatment of ALL/LBL in June 2021 and was added to the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) in July 2021.3
About Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Rylaze, also known as JZP458, is approved in the U.S. for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients one month or older who have developed hypersensitivity to E. coli-derived asparaginase. Rylaze has orphan drug designation for the treatment of ALL/LBL in the United States. Rylaze is a recombinant erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. JZP458 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in October 2019 for the treatment of this patient population. Rylaze was approved as part of the Real-Time Oncology Review program, an initiative of the FDA's Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients.
The full U.S. Prescribing Information for Rylaze is available at: https://pp.jazzpharma.com/pi/rylaze.en.USPI.pdf
For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
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SOURCE Jazz Pharmaceuticals plc
Jazz Pharmaceuticals files for US approval of new dosing schedule of Rylaze
Feb. 02, 2022 9:36 AM ET
Jazz Pharmaceuticals plc (JAZZ)
By: Ravikash, SA News Editor
Jazz Pharmaceuticals (JAZZ -0.5%) completed the submission of a supplemental biologics license application to the U.S. Food and Drug Administration seeking approval for a Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze for use as a component of a multi-agent chemotherapeutic regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients one month and older who have developed hypersensitivity to E. coli-derived asparaginase.
https://seekingalpha.com/symbol/JAZZ
CABENUVA (CABOTEGRAVIR, RILPIVIRINE)
ViiV HEALTHCARE ANNOUNCES US FDA APPROVAL OF CABENUVA (CABOTEGRAVIR, RILPIVIRINE) FOR USE EVERY TWO MONTHS, EXPANDING THE LABEL OF THE FIRST AND ONLY COMPLETE LONG-ACTING HIV TREATMENT
Cabenuva is now approved for administration as few as six times a year for virologically suppressed adults living with HIV without prior treatment failure or resistance to cabotegravir or rilpivirine
London, 1 February 2022 – ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Limited (Shionogi) as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva (cabotegravir, rilpivirine) for every-two-month dosing for the treatment of HIV-1 in virologically suppressed adults (HIV-1 RNA less than 50 copies per millilitre [c/ml]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
Cabenuva is the first and only complete long-acting HIV treatment regimen and was first approved by the US FDA in January 2021 as a once-monthly treatment for HIV-1 in virologically suppressed adults.1 It contains ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The US FDA approval allows Cabenuva to be dosed monthly or every two months.
About ATLAS-2M (NCT03299049)
The ATLAS-2M phase IIIb trial is an ongoing, randomised, open-label, active-controlled, multicentre, parallel-group trial designed to assess the non-inferior antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every eight weeks (every two months, 3ml dose of each medicine) compared to every four weeks (once monthly, 2ml dose of each medicine) over a 48-week treatment period in 1,045 adults living with HIV-1.2 Subjects were required to be virologically suppressed for six months or greater, on a first or second antiretroviral regimen, with no prior virologic failure. The primary outcome measure for the trial was the proportion of participants with HIV-1 RNA ≥ 50 c/ml at Week 48 using the US FDA Snapshot algorithm (intent-to-treat exposed population). ATLAS-2M is part of ViiV Healthcare’s extensive and innovative clinical trial programme. It is being conducted at research centres in Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden and the United States.
For further information, please see https://clinicaltrials.gov/ct2/show/NCT03299049.
About Cabenuva (cabotegravir, rilpivirine)
Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen. Rilpivirine is approved in the US as a 25mg tablet taken once a day to treat HIV-1 in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35kg with a viral load ≤100,000 HIV RNA c/ml.
INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying.
Long-acting cabotegravir and rilpivirine are approved for use every two months in Canada under the name Cabenuva and in the EU as Vocabria and Rekambys.
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
Important Safety Information for Cabenuva (cabotegravir; rilpivirine) extended-release injectable suspensions
Cabenuva is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
CONTRAINDICATIONS
- Do not use Cabenuva in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine
- Do not use Cabenuva in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort
Please see full Prescribing Information.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE/NYSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.
For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.
GSK is a science-led global healthcare company. For further information please visit www.gsk.com/about-us.
ViiV Healthcare announces FDA approval of two-month dosing of Cabenuva for HIV
Feb. 01, 2022 9:23 AM ET GlaxoSmithKline plc (GSK)SGIOY, JNJ, PFE, SGIOF By: Dulan Lokuwithana, SA News Editor
- ViiV Healthcare, majority-owned by GlaxoSmithKline (NYSE:GSK), announced that the FDA approved an every-two-month dosing regimen of the company’s HIV therapy Cabenuva, a combination of cabotegravir and rilpivirine.
- https://seekingalpha.com/news/3794065-viiv-healthcare-announces-fda-approval-of-two-month-dosing-of-cabenuva-for-hiv
- https://seekingalpha.com/symbol/GSK
- https://seekingalpha.com/symbol/PFE
- https://seekingalpha.com/symbol/SGIOF
- https://seekingalpha.com/symbol/SGIOY
- https://www.cabenuva.com/
biotecMAX™ Sept/Oct/Nov/Dec 2021 & Jan 2022 Insight
Yescarta® (axicabtagene ciloleucel)
January 31, 2022
U.S. FDA Approves New Label Update for CAR T-Cell Therapy Yescarta® Showing Prophylactic Steriod Use Improves Management of Cytokine Release Syndrome
– Updated Toxicity Management Strategy Can Improve Certain Adverse Events Without Compromising the Activity of Yescarta –
SANTA MONICA, Calif.--(BUSINESS WIRE)-- Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved an update to the prescribing information for Yescarta® (axicabtagene ciloleucel) to include use of prophylactic corticosteroids across all approved indications. Yescarta is now the first and only chimeric antigen receptor (CAR) T-cell therapy with information in the label to help physicians manage, and potentially prevent, treatment side effects.
The label update is based on the results of a new safety management cohort (Cohort 6) of the pivotal ZUMA-1 study, which was designed to assess the impact of prophylactic use of corticosteroids and earlier treatment with corticosteroids and/or tocilizumab and prophylactic levetiracetam on the incidence and severity of cytokine release syndrome (CRS) and neurologic events. In the cohort, no Grade ≥3 CRS events occurred [0% (0/39) of patients in Cohort 6 compared to 13% (14/108) in the pivotal Cohorts 1/2]. Grade ≥3 neurologic events occurred in 13% of patients at the time of data cut-off, and one patient experienced a late onset Grade 5 event following the data cut-off [13% (5/39) of patients in Cohort 6 compared to 31% (33/108) in the pivotal Cohorts 1/2]. Cohort 6 shows CRS median time to onset of five days with a range from 1-15 days, and neurotoxicity median time to onset of six days with a range from 1-274 days in patients that experienced these complications.
Additional data recently published shows 68% of patients had no CRS or neurologic events within 72 hours of Yescarta infusion (27/40).1 Helping to address the potential concern that steroid use might impact efficacy, the Cohort 6 one-year update presented at the American Society of Hematology (ASH) in December 2021 suggest that Cohort 6 toxicity management strategy can improve certain adverse events without compromising the activity of Yescarta.2 Patients in Cohort 4 and Cohort 6 were found to have received median cumulative steroid doses that were lower than those used in matched Cohorts 1/2 who received steroids to manage CRS or neurologic events when they occurred.3 [1Oluwole OO, et al. Br J Haematol. 2021;194:690-700 and 2Oluwole OO, et al. 2021 ASH Annual Meeting and Exposition; December 11-14, 2021; Atlanta, GA. Abstract 2832 and 3Topp et al. Br J Haematol. 2021;195(3):388-398.]
“These new data will enable doctors to more easily and confidently manage treatment for patients,” said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. “Since the first approval of Yescarta, Kite has worked closely with physicians to optimize all aspects of CAR T-cell therapy to enable as many patients as possible to have the chance to benefit from this treatment. Our responsibility includes research to expand into new diseases and earlier lines of treatment, but also continuously improving the efficacy and safety of our existing CAR T therapies.”
The ZUMA-1 study also included Cohort 4 which was added to the FDA label in May 2021 and evaluated the earlier treatment with corticosteroids and/or tocilizumab and prophylactic levetiracetam. Cohort 6 builds on this growing knowledge regarding how to manage and minimize side effects gained over many years of developing Yescarta. Cohort 6 evaluated 39 patients with relapsed or refractory LBCL. Patients received dexamethasone 10 mg orally once daily for three days, starting prior to Yescarta infusion. In Cohort 6, corticosteroids and tocilizumab were started earlier, at lower grades of CRS and neurologic events, than in the ZUMA-1 pivotal cohorts (Cohorts 1 and 2). All 39 patients received three prophylactic doses of corticosteroids.
Patients can currently access Kite’s CAR T-cell therapies through 111 authorized treatment centers across the U.S. that are experienced in administering and managing patients being treated with CAR T-cell therapy. The Yescarta prescribing information does not specify a treatment setting, whether in the hospital or in near-by outpatient offices with close monitoring. It is up to a patient’s physician to determine the most appropriate treatment setting for their care based on individual circumstances. The Yescarta label update may help physicians manage potential complications and determine appropriate setting for care of their patients.
Yescarta was the first CAR T-cell therapy to be approved by the U.S. FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. Yescarta is also currently under review in the U.S. and European Union for use as an earlier treatment of adult patients with second-line relapsed or refractory LBCL.
About Yescarta
Please see full Prescribing Information, including BOXED WARNING and Medication Guide.
Yescarta is a CD19-directed genetically modified autologous T cell immunotherapy currently indicated for the treatment of:
- Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. - Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
- https://www.yescarta.com/
For more information on Kite, please visit www.kitepharma.com.
U.S. Prescribing Information for Yescarta including BOXED WARNING, is available at www.kitepharma.com and www.gilead.com.
Kite, the Kite logo, Yescarta, Tecartus, XLP and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.
For more information on Kite, please visit the company’s website at www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220131005477/en/
Source: Gilead Sciences, Inc.
Gilead’s Kite announces new label update for Yescarta
Jan. 31, 2022 9:45 AM ET Gilead Sciences, Inc. (GILD) By: Dulan Lokuwithana, SA News Editor
- Kite, a subsidiary of Gilead (NASDAQ:GILD) announced that the FDA approved an update to the prescribing information of its CAR T-cell therapy Yescarta (axicabtagene ciloleucel), allowing the use of corticosteroids across all its indications to manage the adverse events.
- https://seekingalpha.com/news/3793535-gileads-kite-announces-new-label-update-for-yescarta
- https://seekingalpha.com/symbol/GILD
- https://www.yescarta.com/
- https://www.gilead.com/
VONVENDI® [von Willebrand factor (recombinant)]
FDA Approves Prophylactic Treatment with VONVENDI® [von Willebrand Factor (Recombinant)] for Adult Patients Living with Severe Type 3 von Willebrand Disease (VWD)
January 31, 2022
- VONVENDI [von Willebrand Factor (Recombinant)] is the First and Only Treatment Approved for Routine Prophylaxis to Reduce the Frequency of Bleeding Episodes in Adults Living with Severe Type 3 VWD Receiving On-Demand Therapy
- VWD is the Most Common Inherited Bleeding Disorder, Affecting up to Three Million (or About One in Every 100) People in the United States1
CAMBRIDGE, Massachusetts, January 31, 2022 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food & Drug Administration (FDA) approved VONVENDI® [von Willebrand factor (Recombinant)] for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease (VWD) receiving on-demand therapy.
VONVENDI is the only recombinant von Willebrand factor (VWF) replacement therapy, and the first and only treatment to reduce the frequency of bleeding episodes for severe Type 3 VWD approved by the FDA for routine prophylactic use. VONVENDI is now indicated for routine prophylaxis in adults with severe Type 3 VWD receiving on-demand therapy, as well as on-demand and perioperative bleed management in adults with VWD.
“This approval is a major advancement for those living with severe Type 3 VWD and is a testament to Takeda's commitment to improve VWD care,” said Heather Dean, Vice President, U.S. Hematology Franchise Head, Takeda. “With routine prophylactic treatment, there is now a proactive strategy available for management of bleeding episodes and may offer people living with severe Type 3 VWD hope that bleed reduction is possible.”
VWD is an inherited disorder that affects women and men equally.1 It is caused by a deficiency or defective function of VWF, one of several types of proteins in the blood that are needed for proper blood clotting.1 Due to this defective function or deficiency, blood is not able to clot effectively in people with VWD. VONVENDI is an infused product that is specifically designed to replace the body's missing or dysfunctional VWF.1
“VWD is a complex disease where both patients and providers may experience stress and uncertainty due to the unpredictable disease course and limited treatment options,” said Miguel A. Escobar, M.D., professor in the Department of Pediatrics and Internal Medicine at the McGovern Medical School at The University of Texas Health Science Center at Houston and an investigator in the VONVENDI prophylaxis study*. “A prophylactic treatment option may allow for greater disease control and the potential to enhance the standard of care.”
The approval is based on data from a prospective, open-label, international multicenter study to evaluate efficacy and safety of prophylactic treatment in reducing the frequency of bleeding episodes in 10 adult patients diagnosed with severe Type 3 VWD who were previously treated on-demand. Based on descriptive statistics, the median annualized bleeding rates (ABR) for all bleeds (treated and untreated spontaneous and traumatic bleeding events) was reduced from historical median ABR 5.0 (range: 3.0, 159.0) to an on-study median ABR of 2.3 (range: 0, 157.9), which is a 54.7% reduction. The most common adverse reactions (≥2% of subjects) observed in adult patients treated with VONVENDI in clinical trials were headache, vomiting, nausea, dizziness, arthralgia, joint injury, vertigo, ALT increased and generalized pruritus.
VONVENDI [von Willebrand factor (Recombinant)] Important Information
What is VONVENDI?
VONVENDI is used in adults (age 18 years and older) diagnosed with von Willebrand disease to:
- treat and control bleeding episodes
- prevent excessive bleeding during and after surgery
- reduce the number of bleeding episodes when used regularly (prophylaxis) in adults with severe Type 3 von Willebrand disease receiving on-demand therapy.
For more information, visit https://www.takeda.com.
Takeda announces FDA approval of Vonvendi for prophylaxis in bleeding disorder
Jan. 31, 2022 10:40 AM ET
Takeda Pharmaceutical Company Limited (TAK)
By: Dulan Lokuwithana, SA News Editor
- Takeda Pharmaceutical (NYSE:TAK) announced that the FDA approved its oral therapeutic, Vonvendi, for routine prophylaxis in patients with severe Type 3 von Willebrand disease (VWD) receiving on-demand therapy.
- https://seekingalpha.com/news/3793559-takeda-announces-fda-approval-of-vonvendi-for-prophylaxis-in-bleeding-disorder
- https://seekingalpha.com/symbol/TAK
- https://www.vonvendi.com/
- https://www.takeda.com/en-us/
- Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan,
Omnipod® 5 Automated Insulin Delivery System
Jan 28, 2022
Insulet Announces FDA Clearance of its Omnipod® 5 Automated Insulin Delivery System, First Tubeless System with Smartphone Control
ACTON, Mass.--(BUSINESS WIRE)--Jan. 28, 2022-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its Omnipod® 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged six years and older with type 1 diabetes. Omnipod 5 is the first tubeless automated insulin delivery (AID) system that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone to automatically adjust insulin and help protect against highs and lows.
Omnipod® 5 Automated Insulin Delivery System (Photo: Business Wire)
Omnipod 5 is designed to make it easier than ever to manage glucose with no multiple daily injections, no tubes, and zero fingersticks1 to help simplify life with diabetes.
“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” said Shacey Petrovic, President and Chief Executive Officer of Insulet. “We are incredibly proud of this simple-to-use, elegant system, designed to deliver unmatched freedom and to greatly simplify insulin management and improve glucose control for our users.”
The Omnipod 5 System2 consists of the tubeless Pod enhanced with SmartAdjust™ technology, the Dexcom G6 CGM, and the Omnipod 5 mobile app with its integrated SmartBolus Calculator. The user has the option to download this app onto a compatible personal smartphone or to use the Omnipod 5 Controller, which is provided free with the first prescription.
Every five minutes, SmartAdjust receives a Dexcom CGM value and trend, and predicts where glucose will be 60 minutes into the future. The system then increases, decreases, or pauses insulin delivery using the user’s desired and customized glucose target, helping to protect against highs and lows.
“As the pioneer of integrated CGM, we are excited to see our years of collaborative work with Insulet culminate into the first and only FDA-cleared tubeless automated insulin delivery system,” said Kevin Sayer, Chairman, President and CEO of Dexcom. “Omnipod 5 combines the accuracy and unmatched user experience of the Dexcom G6 CGM with the simplicity of tubeless insulin delivery to offer people with diabetes a revolutionary new way to optimize time in range.”
Omnipod 5 will launch through the pharmacy channel, providing customer benefits of no contract, no commitment, and no obligation. In the coming days, Insulet will offer Omnipod 5 in a limited market release so that the Company can incorporate learnings to deliver a best-in-class product experience. Omnipod 5 is expected to be broadly available shortly after the limited market release.
Omnipod 5 was recently selected as a CES® 2022 Innovation Award honoree in two categories: Health and Wellness and Wearable Technologies. The CES Innovation Awards is an annual competition honoring outstanding design and engineering in consumer technology products.
People with diabetes can enjoy the benefits of Pod Therapy today through OmnipodPromise™, which allows new and existing users to start on Omnipod DASH® and upgrade to Omnipod 5 at no additional cost when coverage is available.
To learn more, visit the Omnipod website.
Insulet will provide additional details about today’s announcement on the Company’s fourth quarter 2021 earnings conference call on February 23, 2022 at 4:30 p.m. (Eastern Time). The link to the live call will be available here and will be archived for future replay. To participate in the live call via phone, please pre-register online here to receive a telephone number, passcode, and a unique registrant ID required to enter the call.
For more information, please visit insulet.com and omnipod.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220127006047/en/
Source: Insulet Corporation
FDA clears Insulet's Omnipod 5 automated insulin delivery system
Jan. 28, 2022 6:32 AM ET Insulet Corporation (PODD) By: Mamta Mayani, SA News Editor
- Insulet (NASDAQ:PODD) has received clearance from the FDA for its Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for individuals aged six years and older with type 1 diabetes.
- https://seekingalpha.com/news/3792930-fda-clears-insulets-omnipod-5-automated-insulin-delivery-system
- https://seekingalpha.com/symbol/PODD
- https://insulet.com/
- https://www.omnipod.com/hcp/products/omnipod-system
- https://www.omnipod.com/
- https://www.omnipod.com/what-is-omnipod
DUPIXENT® (DUPILUMAB)
January 31, 2022 at 12:59 AM EST Back
CHMP RECOMMENDS APPROVAL OF DUPIXENT® (DUPILUMAB) FOR CHILDREN AGED 6 TO 11 YEARS WITH SEVERE ASTHMA WITH TYPE 2 INFLAMMATION
TARRYTOWN, N.Y. and PARIS, Jan. 31, 2022 /PRNewswire/ --
Recommendation based on pivotal trial that showed Dupixent significantly reduced severe asthma attacks and improved lung function in children aged 6 to 11 years
Dupixent is the only biologic to show improved lung function in a randomized Phase 3 trial for children
Data further reinforce well-established safety profile of Dupixent
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending to extend the approval of Dupixent® (dupilumab) in the European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies. The European Commission is expected to announce a final decision on the Dupixent application in the coming months.
The CHMP positive opinion is supported by Phase 3 data recently published in the New England Journal of Medicine showing that Dupixent added to standard of care significantly reduced the rate of severe asthma attacks and rapidly improved lung function within two weeks, with sustained improvement up to 52 weeks, in children with uncontrolled moderate-to-severe asthma. The safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with uncontrolled moderate-to-severe asthma. Adverse events more commonly observed with Dupixent compared to placebo included injection site reactions, viral upper respiratory tract infections and eosinophilia. Helminth infections were also more commonly observed with Dupixent compared to placebo in patients aged 6 to 11 years.
Asthma is one of the most common chronic diseases in children. Up to 85% of children with asthma may have type 2 inflammation and are more likely to have higher disease burden. Despite treatment with current standard-of-care inhaled corticosteroids (ICS) and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. Severe asthma may impact children's developing airways and cause potentially life-threatening exacerbations. Children with severe asthma also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Uncontrolled severe asthma can interfere with day-to-day activities like sleeping, attending school and playing sports.
On October 20, 2021, Dupixent was approved by the FDA as an add-on maintenance treatment for patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. The use of Dupixent in children aged 6 to 11 years with uncontrolled severe asthma is investigational in the EU and is not yet approved.
About Dupixent
Dupixent, which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Dupixent is currently approved in Europe for adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO, who are inadequately controlled with high-dose ICS plus another medicinal product for maintenance treatment. It is also approved in the U.S., Japan and other countries around the world for use in certain patients with asthma, specific patients with moderate-to-severe atopic dermatitis as well as CRSwNP in different age populations. Dupixent is also approved in one or more of these indications in more than 60 countries around the world, and more than 350,000 patients have been treated globally.
Dupilumab Development Program
Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes including chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3), allergic bronchopulmonary aspergillosis (Phase 3) and peanut allergy (Phase 2). These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority.
U.S. Indications
DUPIXENT is a prescription medicine used:
- to treat adults and children 6 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 years of age.
- with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. DUPIXENT is not used to treat sudden breathing problems. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age.
- with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyposis under 18 years of age.
Please see accompanying full Prescribing Information including Patient Information.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
View original content:https://www.prnewswire.com/news-releases/chmp-recommends-approval-of-dupixent-dupilumab-for-children-aged-6-to-11-years-with-severe-asthma-with-type-2-inflammation-301470938.html
SOURCE Regeneron Pharmaceuticals, Inc.
EMA OKs expanded use of Regeneron/Sanofi's asthma med Dupixent in kids aged 6 to 11
Jan. 31, 2022 5:50 AM ET Regeneron Pharmaceuticals, Inc. (REGN), SNY By: Mamta Mayani, SA News Editor
- Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) announce that the EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending to extend the approval of Dupixent (dupilumab) in European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation.
- https://seekingalpha.com/news/3793371-ema-oks-expanded-use-of-regeneronsanofis-asthma-med-dupixent-in-kids-aged-6-to-11
- https://seekingalpha.com/symbol/SNY
- https://seekingalpha.com/symbol/REGN
- https://www.regeneron.com/
- https://www.dupixent.com/
February 1, 2022 at 4:29 PM EST
POSITIVE DUPIXENT® (DUPILUMAB) DATA ACROSS FIVE DISEASES WITH UNDERLYING TYPE 2 INFLAMMATION TO BE PRESENTED AT 2022 AAAAI ANNUAL MEETING
TARRYTOWN, N.Y. and PARIS, Feb. 1, 2022 /PRNewswire/ --
Late-breaking pivotal data show significant disease improvements in eosinophilic esophagitis and also in chronic spontaneous urticaria
18 abstracts add to body of evidence that IL-4 and IL-13 pathways inhibited by Dupixent are key drivers of the type 2 inflammation underlying certain diseases, accounting for the impact of Dupixent in its approved and investigational indications
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive Dupixent® (dupilumab) data across five diseases with underlying type 2 inflammation will be presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting from February 25 to 28.
VABYSMO (faricimab-svoa)
Friday, Jan 28, 2022
FDA Approves Genentech’s Vabysmo, the First Bispecific Antibody for the Eye, to Treat Two Leading Causes of Vision Loss
Vabysmo (faricimab-svoa) targets and inhibits two disease pathways that drive wet age-related macular degeneration (AMD) and diabetic macular edema (DME)
Vabysmo is the only injectable eye medicine approved simultaneously in the US for wet AMD and DME, with flexible dosing regimens based on patient need
South San Francisco, CA -- January 28, 2022 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Vabysmo ™ (faricimab-svoa) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Wet AMD and DME are two leading causes of vision loss among U.S. adults. Vabysmo targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Vabysmo is the first and only FDA-approved injectable eye medicine for wet AMD and DME that improves and maintains vision with treatments from one to four months apart in the first year following four initial monthly doses, based on evaluation of the patient’s anatomy and vision outcomes. Standard of care for wet AMD and DME typically requires eye injections every one to two months.
“Vabysmo represents an important step forward for ophthalmology. It is the first bispecific antibody approved for the eye and a major advance in treating retinal conditions such as wet AMD and diabetic macular edema,” said Charles Wykoff, M.D., Ph.D., Director of Research at Retina Consultants of Texas in Houston and a Vabysmo Phase III investigator. “With Vabysmo, we now have the opportunity to offer patients a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time.”
The approval is based on positive results across four Phase III studies in wet AMD and DME. The studies consistently showed that patients treated with Vabysmo given at intervals of up to four months achieved non-inferior vision gains versus aflibercept given every two months in the first year. Vabysmo was generally well tolerated in all four studies, with a favorable benefit-risk profile. The most common adverse reaction (≥5%) reported in patients receiving Vabysmo was conjunctival hemorrhage (7%).
Two scientific papers and an editorial on these one-year results were recently published in The Lancet.
Vabysmo is designed to block pathways involving Ang-2 and VEGF-A. Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. While additional research continues, inhibition of both pathways has been shown in preclinical studies to have potentially complementary benefits, stabilizing vessels and thereby reducing vessel leakage and inflammation.
“Vabysmo provides a new approach to treating vision-threatening retinal conditions through a mechanism of action that targets two pathways simultaneously,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “This is our second FDA approval in ophthalmology in recent months, underscoring our commitment to people living with retinal conditions.”
With Vabysmo, people with wet AMD initially receive four monthly treatments. Based on anatomical and vision outcomes, they may receive subsequent treatments every two, three or four months. People with DME are initially given four monthly treatments. Subsequently their treatment may be extended or reduced based on anatomical and vision outcomes, with a range of one to four months between doses. A second approved treatment regimen for DME involves six monthly loading doses, followed by treatment every two months. Some people with wet AMD and DME may be treated monthly if needed, although additional efficacy was not demonstrated in most patients given Vabysmo every month.
Genentech has ongoing long-term extension studies for Vabysmo in people with wet AMD and DME. These include AVONELLE-X, an extension study of TENAYA and LUCERNE evaluating the long-term safety and tolerability of Vabysmo in wet AMD, and RHONE-X, an extension study of YOSEMITE and RHINE evaluating the long-term safety and tolerability of Vabysmo in DME. Additionally, the COMINO and BALATON trials are also underway, evaluating the efficacy and safety of Vabysmo in people with macular edema following retinal vein occlusion.
Vabysmo will be available in the United States in the coming weeks. The European Medicines Agency is also currently evaluating the Vabysmo Marketing Authorization Application for the treatment of wet AMD and DME.
Genentech is committed to helping people access the medicines they are prescribed and will be offering comprehensive services for people prescribed Vabysmo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at 866-4ACCESS/866-422-2377 or http://www.Genentech-Access.com.
About the TENAYA and LUCERNE Studies
TENAYA (NCT03823287) and LUCERNE (NCT03823300) are two identical, randomized, multicenter, double-masked, global Phase III studies evaluating the efficacy and safety of Vabysmo compared to aflibercept in 1,329 people living with wet age-related macular degeneration (671 in TENAYA and 658 in LUCERNE). The studies each have two treatment arms: Vabysmo 6.0 mg administered at intervals of two, three, or four months, following four initial monthly doses, selected based on objective assessment of disease activity as measured by optical coherence tomography and visual acuity evaluations at weeks 20 and 24; and aflibercept 2.0 mg administered at fixed two-month intervals after three initial monthly doses. In both arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants.
The primary endpoint of the studies is the average change in best-corrected visual acuity (BCVA) score (the best distance vision a person can achieve – including with correction such as glasses – when reading letters on an eye chart) from baseline, averaged over weeks 40, 44 and 48. Secondary endpoints include: safety; the percentage of participants in the Vabysmo arm receiving treatment every two, three and four months; the percentage of participants achieving a gain, and the percentage avoiding a loss, of 15 letters or more in BCVA from baseline over time; change in central subfield thickness (CST) from baseline over time; and change in total area of choroidal neovascularization (CNV) lesion and leakage from baseline over time.
Both studies met their primary endpoint, with Vabysmo given at intervals of up to every four months consistently shown to offer visual acuity gains that were non-inferior to aflibercept given every two months. In TENAYA and LUCERNE, the average vision gains from baseline at one year in the Vabysmo arms were +5.8 and +6.6 letters, respectively, compared to +5.1 and +6.6 letters in the aflibercept arms.
The studies also measured the proportion of people in the Vabysmo arm that were treated on dosing schedules of every three or four months during the first year. In both studies, comparable reductions in central subfield thickness (CST) and CNV size and area of leakage were observed with Vabysmo given at intervals of up to four months versus aflibercept given every two months in the first year. Vabysmo was generally well-tolerated in both studies, with a favorable benefit-risk profile. In TENAYA and LUCERNE, the most common adverse reactions (≥3% of patients) included conjunctival hemorrhage, vitreous floaters, retinal pigment epithelial (RPE) tears, increase of intraocular pressure and eye pain. Safety results were consistent across study arms.
About the YOSEMITE and RHINE Studies
YOSEMITE (NCT03622580) and RHINE (NCT03622593) are two identical, randomized, multicenter, double-masked, global Phase III studies evaluating the efficacy and safety of Vabysmo compared to aflibercept in 1,891 people with diabetic macular edema (940 in YOSEMITE and 951 in RHINE). The studies each have three treatment arms: Vabysmo 6.0 mg administered up to every four months after four initial monthly doses using a treat-and-extend approach; Vabysmo 6.0 mg administered at two-month intervals after six initial monthly doses; and aflibercept administered at fixed two-month intervals after five initial monthly doses. Dosing schedule for patients within the treat-and-extend arm was determined by CST and visual acuity. In all three arms, sham injections were administered at study visits when treatment injections were not scheduled, to maintain the masking of investigators and participants.
The primary endpoint of the studies is the average change in BCVA score from baseline at one year, averaged over weeks 48, 52 and 56. Secondary endpoints included: safety; the percentage of participants in the treat-and-extend arm receiving Vabysmo every one, two, three and four months, at week 52; the percentage of participants achieving a two-step or greater improvement from baseline in diabetic retinopathy severity at week 52; the percentage of participants achieving a gain, and the percentage avoiding a loss, of 15 letters or more in BCVA from baseline over time; change in CST from baseline over time; and percentage of patients with absence of intraretinal fluid over time.
Both studies met their primary endpoint, with Vabysmo at intervals of up to every four months consistently shown to offer visual acuity gains that were non-inferior to aflibercept given every two months. In YOSEMITE, the average vision gains from baseline at one year were +11.6 and +10.7 eye chart letters in the Vabysmo treat-and-extend and two-month arms, respectively, and +10.9 letters in the aflibercept arm. In RHINE, the average vision gains from baseline at one year were +10.8 and +11.8 letters in the Vabysmo treat-and-extend and two-month arms, respectively, and +10.3 letters in the aflibercept arm.
A secondary endpoint in both studies measured the proportion of people in the Vabysmo treat-and-extend arm that achieved dosing schedules of every three or four months at the end of the first year. In both studies, greater reductions in CST and intraretinal fluid were observed with Vabysmo given at intervals of up to four months versus aflibercept given every two months in the first year. Vabysmo was generally well-tolerated in both studies, with a favorable benefit-risk profile. In YOSEMITE and RHINE, the most common adverse reactions (≥3% of patients) included conjunctival hemorrhage, vitreous floaters and increase of intraocular pressure. Safety results were consistent across study arms.
About Vabysmo™ (faricimab-svoa)
Vabysmo (faricimab-svoa) is the first bispecific antibody approved for the eye. It targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilizing blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels.
Vabysmo U.S. Indications
Vabysmo (faricimab-svoa) is a prescription medicine given by injection into the eye, used to treat adults with neovascular (wet) age‑related macular degeneration (AMD) and diabetic macular edema (DME).
Please see additional Important Safety Information in the full Vabysmo Prescribing Information.
For additional information about the company, please visit http://www.gene.com.
FDA approves Genentech’s Vabysmo to treat two causes of vision loss
Jan. 30, 2022 11:50 PM ET Roche Holding AG (RHHBY)
By: Mamta Mayani, SA News Editor
- Genentech, a member of the Roche Group (OTCQX:RHHBY) announces that the FDA has approved Vabysmo (faricimab-svoa) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME).
- https://seekingalpha.com/news/3793344-fda-approves-genentechs-vabysmo-to-treat-two-causes-of-vision-loss
- https://seekingalpha.com/symbol/RHHBY
- https://www.gene.com/patients/medicines/vabysmo
LORVIQUA® (lorlatinib)
European Commission Approves LORVIQUA® (lorlatinib) as a First-Line Treatment for ALK-Positive Advanced Lung Cancer
Friday, January 28, 2022 - 09:46am
Approval based on results from Phase 3 CROWN trial, showing LORVIQUA reduced risk of disease progression or death by 72% in newly diagnosed individuals compared to XALKORI® (crizotinib)
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) granted marketing authorization for LORVIQUA® (lorlatinib, available in the U.S. under the brand name LORBRENA®) as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor.
“For more than a decade, Pfizer has worked tirelessly in its pursuit to help transform the trajectory for people living with advanced, biomarker-driven lung cancers,” said Andy Schmeltz, Global President & General Manager, Pfizer Oncology. “The European Commission’s approval of LORVIQUA as a first-line therapy is a significant milestone that we hope will help bring a needed and meaningful difference to those impacted by this deadly disease in Europe.”
The approval for the first-line use of LORVIQUA was based on the results of the pivotal Phase 3 CROWN trial, in which LORVIQUA reduced the risk of disease progression or death by 72% compared to XALKORI® (crizotinib). As a secondary endpoint, the confirmed objective response rate (ORR) was 76% (95% CI, 68 to 83) with LORVIQUA and 58% (95% CI, 49 to 66) with XALKORI. In patients with measurable brain metastases, 82% of patients in the LORVIQUA arm experienced an intracranial response (71% had an intracranial complete response), compared to 23% of XALKORI patients. The CROWN trial is a randomized, open-label, parallel 2-arm trial in which 296 people with previously untreated advanced ALK-positive NSCLC were randomized 1:1 to receive LORVIQUA monotherapy (n=149) or XALKORI monotherapy (n=147).
“The expanded approval for LORVIQUA in Europe is a considerable advancement – especially for the close to 40 percent of patients with ALK-positive metastatic NSCLC who are faced with brain metastases at diagnosis,” said Professor Benjamin Solomon, MBBS, PhD., Department of Medical Oncology at the Peter MacCallum Cancer Centre in Melbourne, Australia. “It is exciting to see the significant data generated from the CROWN trial continuing to support expanded use around the world and providing physicians in Europe with a highly effective option from the onset of their patients’ treatment journey.”
The EC approval of LORVIQUA follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in December 2021. LORVIQUA is approved in the U.S. by the Food and Drug Administration (FDA) under the brand name LORBRENA for the treatment of adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. In 2019, the EC granted conditional marketing authorization for LORVIQUA as a monotherapy for the treatment of adult patients with ALK-positive advanced NSCLC whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI.
About the CROWN Trial of LORVIQUA
In the CROWN trial, patients were required to have an ECOG performance status of 0-2 and ALK-positive NSCLC as identified by the VENTANA ALK (D5F3) CDx assay. The primary endpoint of the CROWN trial was progression-free survival (PFS) based on blinded independent central review (BICR). Secondary endpoints included overall survival (OS) and tumor assessment related data by BICR, including ORR, and duration of response (DOR). In patients with measurable central nervous system (CNS) metastases at baseline, additional outcome measures were intracranial (IC)-ORR and IC-DOR by BICR. The trial is continuing in order to further evaluate the secondary endpoint of OS, which was not mature at the time of analysis.
Overall, the safety profile of LORVIQUA was similar to that reported in previous studies. The most frequent adverse events (AEs) in ≥20% of 149 patients treated with LORVIQUA were edema, weight gain, peripheral neuropathy, cognitive effects, diarrhea, dyspnea and hypertriglyceridemia. Serious AEs occurred in 34% of people treated with LORVIQUA; the most frequently reported serious AEs were pneumonia, dyspnea, respiratory failure, cognitive effects and pyrexia. Fatal AEs occurred in 3.4% of people treated with LORVIQUA. Permanent discontinuation of LORVIQUA due to AEs occurred in 6.7% of people. Detailed results from the CROWN study were published in the November 2020 issue of the New England Journal of Medicine.
About LORVIQUA® (lorlatinib)
LORVIQUA is a TKI that has been shown to be highly active in preclinical lung cancer models harboring chromosomal rearrangements of ALK. LORVIQUA was specifically developed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood brain barrier.
The full U.S. prescribing information for LORBRENA can be found here.
IMPORTANT LORBRENA® (lorlatinib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
Contraindications: LORBRENA is contraindicated in patients taking strong CYP3A inducers, due to the potential for serious hepatotoxicity.
In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Pfizer granted EU approval for Lorviqua as first line therapy for lung cancer
Jan. 28, 2022 10:25 AM ET
By: Dulan Lokuwithana, SA News Editor
- Pfizer (NYSE:PFE) announced that the European Commission (EC) cleared its tyrosine kinase inhibitor, Lorviqua (lorlatinib), for commercialization as a first-line option for a certain group of adult patients with advanced non-small-cell lung cancer (NSCLC).
- https://seekingalpha.com/news/3793126-pfizer-granted-eu-approval-for-lorviqua-as-first-line-therapy-for-lung-cancer
- https://seekingalpha.com/symbol/PFE
- https://www.pfizer.com/
Verzenio® (abemaciclib)
Health Canada Authorizes Verzenio® (abemaciclib) as the First and Only CDK4/6 Inhibitor for patients with HR+ HER2- High Risk Early Breast Cancer
Jan. 27, 2022 8:30 AM ET Eli Lilly and Company (LLY)
- Adding Verzenio to endocrine therapy demonstrated a significant and clinically meaningful reduction in the risk of recurrence in patients with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-), node-positive, high risk early breast cancer and a Ki-67 score of ≥20%
- Verzenio was first authorized in Canada in 2019 for the treatment of estrogen and/or progesterone HR+ HER2-, metastatic breast cancer (mBC)
- TORONTO, Jan. 27, 2022 /CNW/ - Lilly Canada is pleased to announce that Health Canada has authorized Verzenio® (abemaciclib) (tablets), in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on clinicopathological features and a Ki-67 score ≥20%. Ki-67 is a marker of cellular proliferation. Verzenio is the first and only CDK4/6 inhibitor approved for this patient population. Verzenio was previously approved by Health Canada in August 2019 for metastatic breast cancer.
The Verzenio Phase 3 monarchE trial was a randomized (1:1), open-label, multicentre study in adult women and men with HR+ HER2-, node-positive, resected, EBC with clinical and pathological features consistent with a high risk of disease recurrence. In the trial, patients were randomized to receive two years of Verzenio 150 mg twice daily plus physician's choice of standard endocrine therapy (ET), or standard ET alone. Patients in both treatment arms were instructed to continue to receive adjuvant endocrine therapy for up to 5-10 years as recommended by their clinician. At the second interim efficacy analysis, with a median follow-up of 15.5 months, a statistically significant improvement in invasive disease–free survival (IDFS) was observed in patients who received Verzenio plus endocrine therapy versus those who received endocrine therapy alone. Patients treated with Verzenio plus endocrine therapy had a 25.3% reduction in risk of IDFS recurrence or death compared to patients treated with endocrine therapy alone. Consistent benefit was observed across patient stratification subgroups of geographic region, prior chemotherapy, and menopausal status.
At the final IDFS analysis, efficacy results were updated for the intent to treat (ITT) population, with a median follow-up of 19.1 months. Patients treated with Verzenio plus endocrine therapy had a 28.7% reduction in risk of recurrence or death compared to patients treated with ET alone (IDFS HR=0.713, 95% CI: 0.583, 0.871) and the 2-year IDFS rates were 92.3% and 89.3%, respectively. Also, patients treated with Verzenio plus ET had a 31.3% reduction in risk of distant recurrence or death compared to patients treated with ET alone [distant relapse free survival (DRFS) HR=0.687, 95% CI: 0.551, 0.858] and the 2 year DRFS rates were 93.8% and 90.8%, respectively. The most common sites of distance recurrence were bone, liver, and lung. In this efficacy analysis, overall survival data were immature and a total of 106 patients had died (55 deaths (2.0%) in patients treated with Verzenio plus ET and 51 deaths (1.8%) with ET alone).2
Having achieved the study's primary endpoint in the entire enrolled population, a pre-specified analysis of IDFS was also conducted in patients with high-risk clinical and pathological factors and a Ki-67 score ≥20%. This subgroup analysis (N=2,003) included patients with ≥4 positive axillary lymph nodes (ALN), or 1-3 positive ALN with either Grade 3 disease and/or tumour size ≥5 cm, and whose tumours had a Ki-67 score of ≥20%. There was also a statistically significant improvement in IDFS for this pre-specified subgroup of patients receiving Verzenio plus ET compared to those who received ET alone (HR=0.643, 95% CI: 0.475, 0.872, p=0.0042).2
About the monarchE Study
The efficacy of Verzenio plus physician's choice of standard endocrine therapy was evaluated in monarchE, a randomized (1:1), open-label, multicenter study in adult women and men with HR-positive, HER2-negative, node-positive, resected, early breast cancer (EBC) with clinical and pathological features consistent with a high risk of disease recurrence. To be enrolled, all patients had to have HR positive, HER2-negative EBC with tumor involvement in at least 1 axillary lymph node (pALN). Two cohorts of patients were enrolled. To be enrolled in cohort 1, patients needed to have either ≥4 pALN, or pALN 1-3 and tumor grade 3 and/or tumor size ≥ 50 mm. To be enrolled in cohort 2, patients were required to have pALN 1-3 and Ki-67 score of ≥20% as measured in untreated breast tumor tissue, using a clinical trial assay at a central laboratory. For patients in cohort 1 with available untreated breast tissue samples, retrospective central testing of tissue was conducted to establish if the Ki-67 score was ≥20% or < 20% (specified in the protocol as "Ki-67 high" or "Ki-67 low", respectively). The intent to treat (ITT) population included patients from both cohort 1 (n=5120) and cohort 2 (n=517). Randomization to treatment was stratified by prior treatment (neoadjuvant chemotherapy versus adjuvant chemotherapy versus no chemotherapy); menopausal status (premenopausal versus postmenopausal); and region (North America/Europe versus Asia versus other). Men were stratified as postmenopausal.1,2
About Verzenio® (abemaciclib)
Verzenio® (abemaciclib) is a targeted treatment known as a CDK4/6 inhibitor. Verzenio is a non-chemotherapy oral tablet.
Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells, so they may eventually die (based on preclinical studies). Cyclin-dependent kinases (CDK)4/6 are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.
In vitro, continuous exposure to Verzenio inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). Preclinically, Verzenio dosed daily without interruption resulted in reduction of tumour size. Inhibiting CDK4/6 in healthy cells can result in side effects, some of which may be serious. Clinical evidence also suggests that Verzenio crosses the blood-brain barrier. In patients with advanced cancer, including breast cancer, concentrations of Verzenio and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations.
Verzenio is Lilly's first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. Continuous manufacturing is a new and advanced type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology.
INDICATIONS FOR VERZENIO
Early Breast Cancer
Verzenio® (abemaciclib) (tablets) is indicated in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of disease recurrence based on clinicopathological features and a Ki-67 score ≥20 per cent.
Advanced or Metastatic Breast Cancer
Verzenio (abemaciclib) (tablets) is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
- in combination with an aromatase inhibitor in postmenopausal women as initial endocrine-based therapy.
- in combination with fulvestrant in women with disease progression following endocrine therapy. Pre- or perimenopausal women must also be treated with a gonadotropin-releasing hormone (GnRH) agonist.
- as a single agent in women with disease progression following endocrine therapy and at least 2 prior chemotherapy regimens. At least one chemotherapy regimen should have been administered in the metastatic setting, and at least one should have contained a taxane.
- https://www.verzenio.com/
- https://seekingalpha.com/symbol/LLY
- To learn more about Lilly Canada, please visit us at www.lilly.ca.
- https://www.verzenio.com/
- SOURCE Eli Lilly Canada Inc.
BRUKINSA (zanubrutinib)
BeiGene Announces Acceptance of Supplemental New Drug Application in China for BRUKINSA (zanubrutinib) in Chronic Lymphocytic Leukemia with Breakthrough Therapy Designation
Jan 28, 2022 5:00 AM
BRUKINSA was granted its first breakthrough therapy designation in China with this application
The application is supported by SEQUOIA trial results, which demonstrated BRUKINSA’s superiority in efficacy over chemoimmunotherapy
BRUKINSA received the China NMPA conditional approval for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia in June 2020
CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)-- BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) for BeiGene’s BTK inhibitor BRUKINSA (zanubrutinib) as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and granted BRUKINSA breakthrough therapy designation (BTD).
“This is BRUKINSA’s first filing in treatment-naïve CLL supported by the positive global Phase 3 SEQUOIA trial, a remarkable step forward in its global registration program. As presented at ASH, BRUKINSA significantly prolonged progression-free survival and was generally well-tolerated in these patients, with demonstrated superiority over chemoimmunotherapy in the SEQUOIA trial,” commented Jane Huang, M.D., Chief Medical Officer of Hematology at BeiGene. “Together with the filing in Waldenström’s macroglobulinemia, we are hoping to expand the clinical use of this potential best-in-class BTK inhibitor from relapsed or refractory setting to frontline care for the blood cancer community in China.”
The sNDA is supported by clinical results from the randomized, multicenter, global Phase 3 SEQUOIA trial (NCT03336333) comparing BRUKINSA to bendamustine in combination with rituximab (B+R) in patients with treatment-naïve CLL.
As assessed by an independent review committee (IRC), BRUKINSA demonstrated superiority in progression-free survival (PFS) over B+R. With a median follow-up of 26.15 months, the 24-month PFS was 85.5% (95% CI: 80.1, 89.6) with BRUKINSA, compared to 69.5% (95% CI: 62.4, 75.5) with B+R, and the hazard ratio (HR) was 0.42 (95% CI: 0.27, 0.63), p<0.0001. BRUKINSA was generally well tolerated with a safety profile consistent with its broad clinical program, including a low rate of atrial fibrillation.
About Chronic Lymphocytic Leukemia
Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults, with a global incidence of approximately 114,000 new cases in 2017. CLL affects white blood cells or lymphocytes in the bone marrow, Proliferation of cancer cells (leukemia) in the marrow result in reduced ability to fight infection and spread into the blood, which affects other parts of the body including the lymph nodes, liver and spleen.1,2,3 The BTK pathway is a known route that signals malignant B cells and contributes to the onset of CLL.4 Small lymphocytic lymphoma (SLL) is a non-Hodgkin’s lymphoma affecting the B-lymphocytes of the immune system, which shares many similarities to CLL but with cancer cells found mostly in lymph nodes.5
About BRUKINSA
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.
BRUKINSA has received 20 approvals covering 43 countries and regions:
- For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*;
- For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**;
- For the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have received at least one prior therapy (China, June 2020)**;
- For the treatment of MCL in patients who have received at least one prior therapy (Israel, January 2021);
- For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021);
- For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021);
- For the treatment of adult patients with WM who have received at least one prior therapy (China, June 2021)**;
- For the treatment of MCL in adult patients who have received at least one prior therapy (Canada, July 2021);
- For the treatment of MCL in adult patients who have received at least one prior therapy (Chile, July 2021);
- For the treatment of adult patients with MCL who have received at least one previous therapy (Brazil, August 2021);
- For the treatment of adult patients with WM (United States, August 2021);
- For the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen (United States, September 2021)*;
- For the treatment of adult patients with MCL who have received at least one previous therapy (Singapore, October 2021);
- For the treatment of adult patients with WM who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy (Australia, October 2021);
- For the treatment of adult patients with MCL who have received at least one prior therapy (Australia, October 2021);
- For the treatment of adult patients with MCL who have received at least one previous therapy (Russia, October 2021);
- For the treatment of adult patients with MCL who have received at least one previous therapy (Saudi Arabia, November 2021);
- For the treatment of adult patients with WM who have received at least one prior therapy or first-line treatment of patients unsuitable for chemo-immunotherapy (European Union plus Iceland, Lichtenstein, and Norway, November 2021);
- For the treatment of eligible adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of eligible patients unsuitable for chemo-immunotherapy (Great Britain, December 2021); and
- For the treatment of adult patients with MCL who have received at least one previous therapy (Ecuador, December 2021).
To date, more than 20 marketing authorization applications have been submitted for BRUKINSA for various indications.
* This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
** This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.
Please see full U.S. Prescribing Information at www.beigene.com/PDF/BRUKINSAUSPI.pdf and Patient Information at www.beigene.com/PDF/BRUKINSAUSPPI.pdf.
To learn more about BeiGene, please visit www.beigene.ca and follow us on Twitter at @BeiGeneGlobal.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220128005107/en/
Source: BeiGene
BeiGene's Brukinsa application accepted in China for chronic lymphocytic leukemia
Jan. 28, 2022 5:55 AM ET BeiGene, Ltd. (BGNE)
By: Mamta Mayani, SA News Editor
- BeiGene (NASDAQ:BGNE) announces its supplemental new drug application (sNDA) for BTK inhibitor BRUKINSA (zanubrutinib) has accepted by China National Medical Products Administration (NMPA) for treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and BRUKINSA has been granted breakthrough therapy designation (BTD).
- https://seekingalpha.com/news/3792918-beigenes-brukinsa-application-accepted-in-china-for-chronic-lymphocytic-leukemia
- https://seekingalpha.com/symbol/BGNE
- https://www.beigene.com/
- https://www.brukinsa.com/
- https://www.hkex.com.hk/Market-Data/Securities-Prices/Equities/Equities-Quote?sym=6160&sc_lang=en
Breyanzi (lisocabtagene maraleucel)
Bristol Myers Squibb Receives Positive CHMP Opinion for CAR T Cell Therapy Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory DLBCL, PMBCL and FL3B
01/28/2022CATEGORY:
Recommendation for approval based on results from TRANSCEND NHL 001, the largest pivotal trial of patients with large B-cell lymphoma after at least two prior therapies, and TRANSCEND WORLD
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), and follicular lymphoma grade 3B (FL3B) after two or more lines of systemic therapy. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
“This positive CHMP opinion is an important milestone that recognizes Breyanzi as a differentiated cell therapy with the potential to address unmet needs for patients in the European Union with aggressive lymphomas who have limited treatment options,” said Anne Kerber, senior vice president, Cellular Therapy Development, Bristol Myers Squibb. “We look forward to the European Commission’s decision as we continue to accelerate our research in cell therapy to develop new treatment options for patients living with difficult-to-treat blood cancers.”
The CHMP adopted a positive opinion based on results from TRANSCEND NHL 001, the largest pivotal trial of patients with R/R LBCL after at least two prior therapies, and additional data from the TRANSCEND WORLD study. The studies evaluated patients with R/R DLBCL, PMBCL and FL3B, including those with a broad range of histologies and high-risk disease, and patients who received Breyanzi in the inpatient and outpatient setting.
The EC is expected to deliver its final decision within 67 days of receipt of the CHMP opinion. The decision will be applicable to all European Union member states and Iceland, Norway and Liechtenstein.*
*Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland and Wales).
About TRANSCEND NHL 001
TRANSCEND NHL 001 is an open-label, multicenter, pivotal Phase 1 study conducted in the United States (U.S.) to determine the safety, antitumor activity and pharmacokinetics of Breyanzi in patients with R/R LBCL, including DLBCL, high-grade B-cell lymphoma (HGL), PMBCL and FL3B. The primary outcome measures included treatment-related adverse events, dose-limiting toxicities and objective response rate. Key secondary outcome measures included complete response rate, duration of response, progression-free survival and overall survival. The TRANSCEND program is a broad clinical program evaluating Breyanzi in multiple hematologic indications and treatment lines.
About TRANSCEND WORLD
TRANSCEND WORLD is a single-arm, multi-cohort, multicenter, Phase 2 study to determine the efficacy and safety of Breyanzi in patients with aggressive B-cell non-Hodgkin lymphoma (NHL). The primary outcome measure was overall response rate. Secondary outcome measures included safety, complete response rate, event-free survival, progression-free survival, overall survival, duration of response, pharmacokinetics and health-related quality of life. The study was conducted in Europe and Japan.
About Breyanzi
Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T cell therapy with a defined composition and 4-1BB costimulatory domain. Breyanzi is administered as a defined composition to reduce variability of the CD8 and CD4 component dose. The 4-1BB signaling domain enhances the expansion and persistence of the CAR T cells.
Breyanzi is approved by the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Breyanzi is also approved in Japan for the treatment of patients with third-line plus R/R LBCL and follicular lymphoma.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.
For more information about Bristol Myers Squibb, visit us at BMS.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20220113005630/en/
Source: Bristol Myers Squibb
Bristol Myers Squibb granted EU recommendation for CAR T therapy in lymphoma
Jan. 28, 2022 7:27 AM ET Bristol-Myers Squibb Company (BMY)
By: Dulan Lokuwithana, SA News Editor
Bristol Myers Squibb (NYSE:BMY) announced that an expert panel of the European Medicines Agency (EMA) recommended its chimeric antigen receptor (CAR) T cell therapy, Breyanzi, as a treatment for three forms of lymphoma.
- https://seekingalpha.com/news/3792973-bristol-myers-squibb-granted-eu-recommendation-for-car-t-therapy-in-lymphoma
- https://seekingalpha.com/symbol/BMY
- https://www.breyanzi.com/
- https://www.bms.com/
ADUHELM® (aducanumab-avwa) 100 mg/mL injection
Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM®
JANUARY 27, 2022 • INVESTOR RELATIONS
CAMBRIDGE, Mass., Jan. 27, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced additional details about the Phase 4 post-marketing confirmatory study, ENVISION, of ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease, including details of the study’s goal for diverse enrollment and primary endpoint.
Biogen aims to enroll 18 percent of U.S. participants in ENVISION from Black/African American and Latinx populations. This goal is reflective of Biogen’s ongoing commitment to increase diversity in clinical trials.
“Historically, patients from diverse backgrounds have been poorly represented in Alzheimer’s disease clinical trials, and we are committed to changing this,” said Priya Singhal M.D., M.P.H., Head of Global Safety & Regulatory Sciences and interim Head of Research & Development at Biogen. “This goal matches the diversity among Americans diagnosed with early Alzheimer’s disease, while at the same time, the trial will generate substantial data to verify the effectiveness of ADUHELM.”
Biogen will implement multiple strategies to help overcome barriers to diverse patient enrollment in Alzheimer’s disease trials, such as, lack of access to medical centers, familiarity with benefit/risk profile of treatment, and financial or logistical burdens.
“It’s important to see this ambitious focus on diversity being prioritized in enrollment and integrated as a key part of the ENVISION clinical trial, so that we can have data from patients who more closely represent what we see in the clinic,” said Dylan Wint, M.D., Cleveland Clinic Lou Ruvo Center for Brain Health, Nevada.
The companies also announced today that the primary endpoint for the global, placebo-controlled ENVISION trial will be measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at 18 months after treatment initiation with ADUHELM. The CDR-SB endpoint is a validated measure of both cognition and function that is widely used in clinical trials of patients with early symptomatic Alzheimer’s disease, is consistent with ADUHELM’s Phase 3 EMERGE and ENGAGE studies, and capable of generating robust outcomes. The update also includes an increase in the previously announced enrollment, from 1,300 to 1,500 people with early Alzheimer’s disease (Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease), with confirmation of amyloid beta pathology, to further strengthen the data provided by the study.
Although ENVISION and other ADUHELM clinical trials are already planned or underway, the Centers for Medicare and Medicaid Services (CMS) recently released a draft National Coverage Determination (NCD), which would restrict Medicare coverage of ADUHELM and other amyloid-targeting therapies to patients enrolled in an additional clinical trial. Biogen is committed to engaging with CMS to avoid unnecessary duplication of clinical trials and work towards finding a path to offer immediate access to patients to the first FDA approved treatment for Alzheimer’s disease since 2003.
In addition to the primary endpoint, CDR-SB, secondary endpoints include Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 13), Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Mild Cognitive Impairment Version (ADCS-ADL-MCI), Integrated Alzheimer's Disease Rating Scale (iADRS), Mini-Mental State Examination (MMSE) and Neuropsychiatric Inventory (NPI-10).
The initiation of patient screening for ENVISION is planned for May 2022. Based on enrollment rates from the previous Phase 3 trials with ADUHELM, the primary completion date is expected to be approximately four years after the study begins. The companies are grateful to the healthcare professionals, medical centers, patients and families who will participate in this trial.
Previously, in July 2021, the companies set another substantial diversity goal in the observational Phase 4 ICARE AD trial, which aims to enroll a total of approximately 6,000 patients.
About ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use
ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
ADUHELM is a monoclonal antibody directed against amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.
ADUHELM can cause serious side effects including: Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a common side effect that does not usually cause any symptoms but can be serious. Although most people do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes and nausea. The patient’s healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA. ADUHELM can also cause serious allergic reactions. The most common side effects of ADUHELM include: swelling in areas of the brain, with or without small spots of bleeding in the brain or on the surface of the brain (ARIA); headache; and fall. Patients should call their healthcare provider for medical advice about side effects.
As of October 2017, Biogen and Eisai Co., Ltd. are collaborating on the global co-development and co-promotion of aducanumab.
Please click here for full Prescribing Information, including Medication Guide, for ADUHELM.
To learn more, please visit www.biogen.com
For more information about Eisai Co., Ltd., please visit https://www.eisai.com.
Biogen/Eisai highlights details for Phase 4 Aduhelm study in Alzheimer's disease
Jan. 27, 2022 8:06 AM ET Biogen Inc. (BIIB), ESALFESALYBy: Mamta Mayani, SA News Editor1 Comment
- Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESALF) announce additional details about the Phase 4 confirmatory study, ENVISION, of Aduhelm (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer’s disease (AD).
- https://seekingalpha.com/news/3792390-biogeneisai-highlights-details-for-phase-4-aduhelm-study-in-alzheimers-disease
- https://seekingalpha.com/symbol/ESALF
- https://seekingalpha.com/symbol/BIIB
Evrysdi (risdiplam)
Monday, Jan 24, 2022
Genentech’s Evrysdi (risdiplam) Granted FDA Priority Review for Treatment of Pre-Symptomatic Babies Under 2 Months of Age With Spinal Muscular Atrophy (SMA)
Interim data submitted to the FDA show majority of pre-symptomatic babies treated with Evrysdi for at least one year were able to sit, stand and walk within timeframes typical of healthy babies, as well as maintain swallowing
Evrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to date
South San Francisco, CA -- January 24, 2022 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of a supplemental new drug application (sNDA) for the use of Evrysdi® (risdiplam) to treat pre-symptomatic babies under two months of age with spinal muscular atrophy (SMA). The sNDA submission incorporates interim data from the RAINBOWFISH study, which shows the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting, standing, walking and maintained the ability to swallow following 12 months of treatment.
“Treating very young babies with Evrysdi before SMA symptoms arise may help them to achieve milestones such as standing and walking within timeframes typical of healthy infants,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “Extending treatment access for the youngest members of the SMA community is crucial and we look forward to working with the FDA on this application.”
Evrysdi is designed to treat SMA by increasing and sustaining production of the survival motor neuron (SMN) protein in the central nervous system (CNS) and peripheral tissues. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement. Evrysdi’s existing FDA label is for the treatment of SMA in adults, children and babies two months and older. If approved, Evrysdi would be the first medicine administered at home for pre-symptomatic babies with SMA.
Initial interim data from the RAINBOWFISH study, presented at the World Muscle Society (WMS) Virtual Congress 2021, showed that of the babies included in the interim efficacy analysis, all (5/5), maintained the ability to swallow and were able to feed exclusively orally after 12 months of treatment. Eighty percent (4/5) treated with Evrysdi for at least 12 months achieved milestones such as standing and walking independently within World Health Organization windows for healthy children. All participants (n=5) met Hammersmith Infant Neurological Examination, Section 2 (HINE-2) motor milestones of head control, sitting upright, rolling and crawling after 12 months of treatment with Evrysdi.
No treatment-related serious adverse events were reported in any of the babies treated with Evrysdi through the interim safety analysis period (n=12). Four treatment-emergent adverse events were reported, and all were resolved or were resolving with ongoing treatment with Evrysdi. The most common adverse events (AEs) were nasal congestion (33%), cough (25%), teething (25%), vomiting (25%), eczema (17%), abdominal pain (17%), diarrhea (17%), gastroenteritis (17%), papule (17%) and pyrexia (17%). The AEs were reflective of the age of the babies rather than the underlying SMA. The RAINBOWFISH study is currently recruiting.
The latest results from the RAINBOWFISH study will be presented at the Muscular Dystrophy Association (MDA) Clinical and Scientific Conference in March 2022.
Genentech leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.
About Evrysdi® (risdiplam)
Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to survival motor neuron (SMN) protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube.
Evrysdi is designed to treat SMA by increasing and sustaining the production of SMN protein levels in the central nervous system (CNS) and peripheral tissues as demonstrated in animal models. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.
Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S Food and Drug Administration in 2017. In 2021, Evrysdi was awarded Drug Discovery of the Year by the British Pharmacological Society as well as the Society for Medicines Research Award for Drug Discovery. Evrysdi is currently approved in 70 countries and the dossier is under review in a further 31 countries.
Evrysdi is currently being evaluated in five multicenter trials in people with SMA:
- FIREFISH (NCT02913482) – an open-label, two-part pivotal clinical trial in infants with Type 1 SMA. Part 1 was a dose-escalation study in 21 infants with the primary objective of assessing the safety profile of Evrysdi in infants and determining the dose for Part 2. Part 2 is a pivotal, single-arm study of Evrysdi in 41 infants with Type 1 SMA treated for 2 years, followed by an open-label extension. Enrollment for Part 2 was completed in November 2018. The primary objective of Part 2 was to assess efficacy as measured by the proportion of infants sitting without support after 12 months of treatment, as assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development – Third Edition (BSID-III) (defined as sitting without support for 5 seconds). The study met its primary endpoint.
- SUNFISH (NCT02908685) – SUNFISH is a two part, double-blind, placebo controlled pivotal study in people aged 2-25 years with Types 2 or 3 SMA. Part 1 (n=51) determined the dose for the confirmatory Part 2. Part 2 (n=180) evaluated motor function using the total score of Motor Function Measure 32 (MFM-32) at 12 months. MFM-32 is a validated scale used to evaluate fine and gross motor function in people with neurological disorders, including SMA. The study met its primary endpoint.
- JEWELFISH (NCT03032172) – an open-label exploratory trial designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in people with SMA aged 6 months to 60 years (inclusion criteria) who received other investigational or approved SMA therapies for at least 90 days prior to receiving Evrysdi. The study has completed recruitment (n=174).
- RAINBOWFISH (NCT03779334) – an open-label, single-arm, multicenter study, investigating the efficacy, safety, PK and PD of Evrysdi in babies (~n=25), from birth to 6 weeks of age (at first dose) with genetically diagnosed SMA who are not yet presenting with symptoms. The study is currently recruiting.
- MANATEE (NCT05115110) – a global phase 2/3 clinical study to evaluate the safety and efficacy of GYM329 (RO7204239), an anti-myostatin molecule targeting muscle growth, in combination with Evrysdi for the treatment of SMA in patients 2-10 years of age. The FDA Office of Orphan Products Development granted GYM329 Orphan Drug Designation for the treatment of patients with SMA in December 2021. The study is commencing recruitment in Q1 2022.
What is Evrysdi?
Evrysdi is a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older.
It is not known if Evrysdi is safe and effective in children under 2 months of age.
Please see the full Prescribing Information for additional Important Safety Information.
For additional information about the company, please visit http://www.gene.com.
FDA grants priority review to Genentech’s Evrysdi for pre-symptomatic newborn babies with SMA
Jan. 25, 2022 1:48 AM ET Roche Holding AG (RHHBY), PTCT By: Mamta Mayani, SA News Editor
- Roche (OTCQX:RHHBY) unit, Genentech announces that the FDA has granted priority review of a supplemental new drug application (sNDA) for the use of Evrysdi (risdiplam) to treat pre-symptomatic babies under two months of age with spinal muscular atrophy (SMA).
- https://seekingalpha.com/news/3791049-fda-grants-priority-review-to-genentechs-evrysdi-for-pre-symptomatic-newborn-babies-with-sma
- https://seekingalpha.com/symbol/RHHBY
- https://www.evrysdi.com/
Intellis™ rechargeable neurostimulator and Vanta™ recharge-free neurostimulator
JAN 24, 2022
Medtronic announces FDA approval of spinal cord stimulation therapy for treating chronic pain resulting from diabetic peripheral neuropathy
Studies show significant reduction in pain and improved quality of life for patients treated with spinal cord stimulation compared to medication management alone
DUBLIN, Jan. 24, 2022 /PRNewswire(opens new window)/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it has received U.S. Food and Drug Administration approval of its Intellis™ rechargeable neurostimulator and Vanta™ recharge-free neurostimulator for the treatment of chronic pain associated with diabetic peripheral neuropathy (DPN).
DPN is a debilitating and progressive neurological disorder that affects approximately 30% of people with diabetes, significantly impacting both quality of life and functional ability, including mood, social relationships, and sleep.1 DPN occurs when high blood sugar (glucose) damages nerves in the body, most often in the legs and feet, leading to numbness and burning or stabbing pain. In some patients, the pain can become progressively worse and excruciating. Patients may be treated with medications, but they are often only partially effective and can result in serious side effects.
This new indication offers patients with DPN access to Medtronic's industry-leading spinal cord stimulation (SCS) portfolio of rechargeable and recharge-free platforms, which include multiple programming options to personalize patient therapy, unrestricted MRI access2, unrivaled battery chemistry and performance, and the Medtronic TYRX™ Neuro Absorbable Antibacterial Envelope. The surgical management of diabetic patients can be a challenge for health care providers as they often have additional risk factors and are at greater risk for infection.3 The TYRX™ antibacterial surgical mesh envelope has been shown to stabilize device placement and help reduce infection by over 60%.4-10 Clinicians may also advise patients to take advantage of CareGuidePro™, which serves as a virtual guide for patients throughout their SCS journey.
Independent studies show patients with DPN achieve significant pain relief when treated with SCS compared to conventional treatments alone.11,12 Overall, 70% of patients receiving treatment with SCS experienced relief of their pain symptoms compared to 6% of patients receiving only conventional treatments. Those treated with SCS experienced a 53% average reduction in pain, compared to 0% among patients receiving only conventional treatments. A recent meta-analysis showed a significant improvement in health-related quality of life in patients treated with SCS compared to those receiving only conventional treatments.13 A long-term analysis of patients treated in one of the studies using Medtronic SCS technology showed 80% of patients treated with SCS continued to use their devices at five years to treat their pain.14
"DPN is a significant challenge for patients with diabetes, leading to disability and a diminished quality of life," said Charlie Covert, vice president and general manager, Pain Therapies within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "This new indication enables us to apply Medtronic's more than 40 years of proven SCS experience, as well as the company's deep diabetes expertise, to deliver better care to even greater numbers of diabetes patients."
Medtronic estimates that up to 800,000 US patients suffer from moderate to severe DPN symptoms that are not resolved through conventional medical management approaches, like drugs. The company views these patients as potential candidates for SCS, representing an approximate $1.8 billion annual market opportunity. Today, Medtronic estimates that the US market revenue for SCS treatment of chronic pain associated with DPN, sometimes also referred to as Painful Diabetic Neuropathy (PDN), is approximately $70 million, and the company expects market revenue to grow to $300 million by fiscal year 2026.
For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com(opens new window), and follow @Medtronic(opens new window) on Twitter and LinkedIn(opens new window).
Medtronic wins FDA approval for neurostimulators to treat pain in diabetic neuropathy
Jan. 24, 2022 12:54 PM ET Medtronic plc (MDT) By: Dulan Lokuwithana, SA News Editor
- Medtronic (MDT -3.9%) announced that the FDA approved two of its neurostimulators for the treatment of chronic pain linked to diabetic peripheral neuropathy.
- https://seekingalpha.com/news/3790848-medtronic-wins-fda-approval-for-neurostimulators-to-treat-pain-in-diabetic-neuropathy
- https://www.medtronic.com/us-en/healthcare-professionals/products/neurological/spinal-cord-stimulation-systems/vanta-pc-neurostimulator.html
- https://seekingalpha.com/symbol/MDT
WHAT IS A NEUROSTIMULATOR?
Chronic Pain
biotecMAX™ Sept/Oct/Nov/Dec 2021 & Jan 2022 Insight
Veklury® (Remdesivir)
January 21, 2022
FDA Approves Veklury® (Remdesivir) for the Treatment of Non-Hospitalized Patients at High Risk for COVID-19 Disease Progression
-- Approval Based on Phase 3 Data Showing Veklury Significantly Reduced Risk of Hospitalization By 87% Compared with Placebo --
-- NIH Guidelines Recommend Veklury for the Treatment of Non-Hospitalized Patients at High Risk --
-- FDA Expands Pediatric Emergency Use Authorization (EUA) to Include Treatment of Non-Hospitalized Pediatric Patients at High Risk --
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted expedited approval of a supplemental new drug application (sNDA) for Veklury® (remdesivir) for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19, including hospitalization or death. This approval expands the role of Veklury, which is the antiviral standard of care for the treatment of patients hospitalized with COVID-19. The expanded indication allows for Veklury to be administered in qualified outpatient settings that can administer daily intravenous (IV) infusions over three consecutive days. The FDA has also expanded the pediatric Emergency Use Authorization (EUA) of Veklury to include non-hospitalized pediatric patients younger than 12 years of age who are at high risk of disease progression.
These actions by the FDA come amidst a surge in COVID-19 cases and the reduced susceptibility to several anti-SARS-CoV-2 monoclonal antibodies (mAbs) due to the Omicron variant. In contrast, Veklury targets the highly conserved viral RNA polymerase, thereby retaining activity against existing SARS-CoV-2 variants of concern. In vitro laboratory testing shows that Veklury retains activity against the Omicron variant. To date, no major genetic changes have been identified in any of the known variants of concern that would significantly alter the viral RNA polymerase targeted by Veklury.
The FDA sNDA approval, pediatric EUA expansion and recently updated National Institutes of Health (NIH) Treatment Guidelines for COVID-19 that additionally recommend Veklury for treatment in non-hospitalized settings, are based on results from the PINETREE Phase 3 randomized, double-blind, placebo-controlled trial. The trial evaluated the efficacy and safety of a three-day course of Veklury for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. An analysis of 562 participants randomly assigned in a 1:1 ratio to receive Veklury or placebo, demonstrated that treatment with Veklury resulted in a statistically significant 87% reduction in risk for the composite primary endpoint of COVID-19 related hospitalization or all-cause death by Day 28 (0.7% [2/279]) compared with placebo (5.3% [15/283]) p=0.008. In the study, no deaths were observed in either arm by Day 28. The safety profile was similar between Veklury and placebo across the variety of outpatient settings in this trial, with the most common treatment emergent adverse events (≥5%) in patients taking Veklury being nausea and headache.
“Remdesivir has now helped to treat more than 10 million people around the world with COVID-19 and continues to play a key role in helping to reduce the burden of the pandemic. Based on the most recent data, we now understand that remdesivir is also effective in the early stages of COVID-19 infection, in addition to helping patients who are hospitalized with the disease,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. “While we continue to advance remdesivir to benefit more patients in multiple settings, we are also advancing our investigational oral compounds. These are based on the same antiviral mechanism of action as remdesivir and a Phase 1 trial for our oral COVID-19 antiviral, GS-5245 is now underway.”
In the United States, Veklury is indicated for the treatment of COVID-19 in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) who are either hospitalized or not hospitalized and are at high risk for progression to severe COVID-19, including hospitalization or death. Veklury is additionally authorized for these uses under the EUA for pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age weighing at least 3.5 kg. Veklury is contraindicated in patients who are allergic to Veklury or any of its components; please see below for additional Important Safety Information for Veklury.
Under the expanded indication for Veklury, non-hospitalized adult and pediatric patients (12 years of age and older and weighing at least 40 kg) with confirmed SARS-CoV-2 infection who are at high risk for COVID-19 disease progression can be treated with a recommended treatment duration of three days to help prevent hospitalization. For hospitalized patients not on mechanical ventilation and/or ECMO, a 5-day course of treatment is recommended, with the option to extend to a total of 10-days as needed. Critically ill patients who require mechanical ventilation and/or ECMO should receive a 10-day course of treatment.
About Veklury
Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19. At this time, more than half of patients hospitalized with COVID-19 in the United States are treated with Veklury. It can help reduce disease progression across a spectrum of disease severity and enable hospitalized patients to recover faster, freeing up limited hospital resources and saving healthcare systems money.
Veklury is approved or authorized for temporary use in approximately 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 10 million patients around the world, including 7 million people in 127 middle- and low-income countries through Gilead’s voluntary licensing program. These licenses currently remain royalty-free, reflecting Gilead’s existing commitment to enabling broad patient access to remdesivir.
U.S. Indication for Veklury
Veklury® (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, who are:
- Hospitalized, or
- Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
Veklury should only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. Veklury must be administered by intravenous infusion. Veklury is contraindicated in patients who are allergic to Veklury or any of its components. For more information, please see the U.S. full Prescribing Information available at www.gilead.com.
U.S. full Prescribing Information for Veklury is available at www.gilead.com.
Veklury, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.
For more information about Gilead, please visit the company’s website at www.gilead.com , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220121005359/en/
Source: Gilead Sciences, Inc.
FDA expands use of Gilead's COVID drug remdesivir to non-hospitalized patients
Jan. 21, 2022 10:35 PM ETGilead Sciences, Inc. (GILD)By: Jonathan Block, SA News Editor8 Comments
- Gilead's (NASDAQ:GILD) COVID-19 treatment Veklury (remdesivir) can now be used in non-hospitalized adults and adolescents at high risk of progressing to severe disease.
- https://seekingalpha.com/news/3790488-fda-expands-use-of-gilead-covid-drug-remdesivir-to-non-hospitalized-patients
- https://seekingalpha.com/symbol/GILD
- https://www.vekluryhcp.com/
TYVYT® (Sintilimab Injection) Plus Bevacizumab Biosimilar Injection
Innovent and Eli Lilly and Company Announced Final Clinical Results and Biomarker Analysis of Phase Ib Study of TYVYT® (Sintilimab Injection) Plus Bevacizumab Biosimilar Injection for Advanced Hepatocellular Carcinoma at ASCO GI Annual Meeting 2022Published on: Jan 22nd, 2022Back
SAN FRANCISCO, U.S. and SUZHOU, China, Jan 21, 2022 — Innovent Biologics, Inc. (“Innovent”, HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today jointly announced with Eli Lilly and Company (“Lilly”, NYSE: LLY) the final clinical outcome and biomarker analysis of the open label, phase Ib study （NCT04072679）of sintilimab plus bevacizumab biosimilar injection for advanced hepatocellular carcinoma at the 2022 ASCO Gastrointestinal Cancers Symposium (Abstract# 455).
The study, which was conducted in China, evaluated the treatment of sintilimab plus bevacizumab biosimilar injection for patients with local advanced or metastatic HCC with or without previous systemic treatment or systemic treatment failure. The Phase Ib study included dose escalation and dose expansion stages. In the dose escalation stage, patients were randomly assigned to receive sintilimab 200mg plus bevacizumab biosimilar 7.5 mg/kg (low-dose group) or 15 mg/kg (high-dose group). In the dose expansion stage safety and efficacy were assessed for each dose group. A total of fifty patients were enrolled in final analysis, with 29 patients administered bevacizumab biosimilar 7.5 mg/kg and 21 patients 15 mg/kg. The safety profile was consistent with that observed in previously reported studies of sintilimab and bevacizumab biosimilar, without new or unexpected safety signals. The most common treatment-related adverse events (TRAE) were as hypertension (32%), proteinuria (26%) and fever (26%). The incidence of grade ≥ 3 adverse events in the high-dose group was 28.6%, while 13.8% in the low-dose group.
The overall response rate (ORR) was 34% (17/50) and ORRs for the low-dose and high-dose groups were 31% and 38%, respectively. The disease control rate (DCR) was 78% (39/50). Median progression-free survival (PFS) was 10.5 months (95%CI, 8.4-12.7) and median overall survival (OS) was 20.2 months (95%CI, 16.1 -24.3). Further biomarker analysis showed that patients with a high level of CD137 ≥ 31.8 pg/mL have longer PFS (mPFS:14.2 vs. 4.1months, p=0.001) and OS (mOS: NR vs.15.6months, p=0.023). In addition, the Tumor immune Microenvironment（TiME）analysis demonstrated that the high density of M1 macrophages (CD68+, CD163-) in stroma was related to higher efficacy (p=0.033), longer PFS (p=0. 024) and OS (p =0.046).
Professor Zhou Aiping from the Cancer Hospital of the Chinese Academy of Medical Sciences stated："This study not only showed the safety and efficacy data for sintilimab in combination with different doses of bevacizumab, but also identified biomarkers that could predict the efficacy of the combined treatment regimen for hepatocellular carcinoma, which lays the groundwork for more individualized treatment.”
About NCT04072679 study
NCT04072679 study is a Phase 1b study assessing the safety, tolerability and anti-tumor activity of sintilimab in combination with bevacizumab biosimilar in subjects with local advanced or metastatic HCC with or without previous systemic treatment or systemic treatment failure in China. The study has two stages, the first is a dose escalation stage and the second is a dose expansion stage. In the dose escalation stage, subjects will receive either 7.5 mg/kg (low-dose group) or 15 mg/kg (high-dose group) of bevacizumab biosimilar (IBI305) in combination with a fixed dose of 200 mg of sintilimab, respectively, and then entered into the dose expansion stage.
About Sintilimab
Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab worldwide, to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.
In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for four indications, including:
- The treatment of relapsed or refractory classic Hodgkin's lymphoma after two lines or later of systemic chemotherapy;
- In combination with pemetrexed and platinum chemotherapy, for the first-line treatment of non-squamous non-small cell lung cancer;
- In combination with gemcitabine and platinum chemotherapy, for the first-line treatment of squamous non-small cell lung cancer;
- In combination with bevacizumab biosimilar for the first-line treatment of unresectable or advanced hepatocellular carcinoma.
Additionally, sintilimab currently has three regulatory submissions accepted for review in NMPA, including:
- In combination with cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil for the first-line treatment of esophageal squamous cell carcinoma;
- In combination with chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma;
- In combination with bevacizumab biosimilar and chemotherapy for EGFR-mutated non-squamous NSCLC following EGFR-TKI treatment.
Additionally, two clinical studies of sintilimab have met their primary endpoints:
- Phase 2 study as second-line treatment of esophageal squamous cell carcinoma;
- Phase 3 study as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.
In May 2021, the U.S. FDA accepted for review the Biologics License Application (BLA) for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of non-squamous non-small cell lung cancer.
About BYVASDA® (bevacizumab biosimilar injection)
BYVASDA®, also known as IBI305, is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF-A selectively with high affinity and blocks its binding to VEGF-2 receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA® produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since its launch, bevacizumab has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab in these tumor types have been well recognized worldwide.
In China, BYVASDA® (bevacizumab biosimilar injection) is approved for indications including advanced non-small cell lung cancer, metastatic colorectal cancer, adult recurrent glioblastoma, and advanced or unresectable hepatocellular carcinoma.
For more information, please visit: www.innoventbio.com.
To learn more about Lilly, please visit us at www.lilly.com
and http://newsroom.lilly.com/social-channels.
About Eli Lilly and Company’s strategic cooperation with Innovent Biologics
Lilly entered into a strategy collaboration with Innovent focused on biological medicine in March 2015 – a groundbreaking partnership between a Chinese pharmaceutical company and a multinational pharmaceutical company. Under the agreement, Lilly and Innovent will co-develop and commercialize oncology medicines, including Tyvyt® (sintilimab injection) in China. In October 2015, the two companies announced the extension of their existing collaboration to include co-development of three additional oncology antibodies targeting oncology indications. In August 2019, Innovent further entered a licensing agreement with Lilly to develop and commercialize a potentially global best-in-class diabetes medicine in China. Its collaboration with Lilly indicates that Innovent has established a comprehensive level of cooperation between China’s innovative pharmaceuticals sector and the international pharmaceuticals sector in fields such as R&D, CMC, clinical development and commercialization.
TYVYT® (sintilimab injection) is not an approved product in the United States.
BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.
TYVYT® (sintilimab injection, Innovent)
BYVASDA® (bevacizumab biosimilar injection, Innovent)
HALPRYZA® (rituximab biosimilar injection, Innovent)
SULINNO® (adalimumab biosimilar injection, Innovent)
Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.
Pemazyre® (pemigatinib)
Innovent Announces the Approval of Pemazyre® (pemigatinib) in Hong Kong Market for the Treatment of Adults With Locally Advanced Or Metastatic Cholangiocarcinoma With A FGFR2 Fusion Or Rearrangement That Have Progressed After At Least One Prior Line Of Systemic Therapy
Jan. 24, 2022 2:13 AM ET
Innovent Biologics, Inc. (IVBIY)
SAN FRANCISCO and SUZHOU, China, Jan. 24, 2022 /PRNewswire/ -- Innovent Biologics, Inc. (IVBIY) (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases announced that the Hong Kong Department of Health (DH) has approved Pemazyre® (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Pemazyre, discovered by Incyte and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan, is the first tyrosine kinase inhibitor approved for the treatment of cholangiocarcinoma, a type of biliary tract cancer, in Hong Kong market, marking a new milestone following the successful approval of Pemazyre in Taiwan in June 2021 and the New Drug Applicant(NDA) acceptance by China's NMPA in July 2021.
The approval was based on the FIGHT-202 study, which is a Phase 2, multi-center, open-label, single-arm study (NCT02924376) evaluating the safety and efficacy of Pemazyre – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement. The major efficacy outcome measure was overall response rate (ORR) determined by an independent review committee Per RECIST V1.1. As data cut of (April 4th,2020), a total of 108 subjects with FGFR 2 fusion/rearrangement was enrolled in the study and received 13.5mg pemigatinib per day, the ORR was 37.0% (95% CI: 27.94%, 46.86%), including 4 complete responses. The median duration of response (DOR) was 8.08 months with responses lasting ≥ 6 months in 26 of the 40 (66.0%) responding patients and ≥ 12 months in 15 (37.5%) patients. The safety analysis, including 147 patients, demonstrated that pemigatinib was generally well tolerated. Hyperphosphatemia was the most common (58.5%) treatment-emergent adverse event (TEAE). TEAEs grade 3 or higher were reported in 68.7% of patients; the most frequent of which were hypophosphatemia (14.3%), arthralgia (6.1%), stomatitis 6.1%), hyponatremia (5.4%), abdominal pain (5.4%) and fatigue (5.4%).
For more information FIGHT-202, please visit https://clinicaltrials.gov/ct2/show/NCT02924376 or https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30109-1/fulltext.
Dr. Yongjun Liu, President of Innovent, stated: "The approval of Pemazyre in Hong Kong, following the approval in Taiwan earlier this year, further broadens Innovent's product portfolio and market coverage. Currently Innovent has developed a robust pipeline of 26 clinical assets and more than 80 projects in preclinical stage, along the way we have established strategic collaborations with a dozen of global and regional partners. We look forward to launching more innovative drugs to help fulfill unmet needs, overcome current therapeutic limitation and improve the life quality of patients."
"Cholangiocarcinoma is the second most common malignancy originated in the liver with a high incidence in Asia. This cancer is usually not diagnosed until it has already developed into an advanced unresectable and/or metastatic stage. There are limitations on current treatment options, which call for innovative drugs that could greatly enhance disease control as well as provide better life quality," stated Dr. Hui Zhou, Senior Vice President of Innovent. "Data from previous clinical trials of Pemazyre in participants with advanced cholangiocarcinoma with FGFR2 fusion that have progressed after at least one prior line of systemic therapy has not only shown satisfactory safety results but also revealed compelling efficacy signals. In addition, Pemazyre is an orally administered medication that could improve convenience and patient compliance. The approval is a new milestone for Innovent; we look forward to hearing good news from NMPA as well and to bringing the therapeutic benefit of Pemazyre in the treatment of eligible patients with cholangiocarcinoma in the Greater China market."
About Pemazyre® (pemigatinib)
In April 2020, the U.S. Food and Drug Administration (FDA) approved Incyte's Pemazyre® (pemigatinib), a selective, oral inhibitor of FGFR isoforms 1, 2 and 3, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
In Japan, Pemazyre® is approved for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre® is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
Pemazyre® is marketed by Incyte in the United States, Europe and Japan.
In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the three assets in Mainland China, Hong Kong, Macau and Taiwan. In March 2020, Innovent announced that the first patient was dosed in the pivotal registrational trial evaluating pemigatinib in patients with advanced cholangiocarcinoma in China.
In June 2021, Taiwan Food and Drug Administration (TFDA) approved Pemazyre® (pemigatinib) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement.
For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.
SOURCE Innovent Biologics
(IVBIY)
https://seekingalpha.com/symbol/IVBIY
https://www.pemazyre.com/?gtm_debug=x
Tislelizumab in Combination with Chemotherapy
BeiGene Announces Positive Findings from Phase 3 Trial of Tislelizumab in Combination with Chemotherapy in First-Line Gastric or Gastroesophageal Junction Cancer
Jan 24, 2022 5:00 AM
In the RATIONALE 305 trial, tislelizumab combined with chemotherapy prolonged overall survival for patients with PD-L1 expression
Additional follow-up is needed to assess overall survival benefits in intention-to-treat patient population
Safety findings of tislelizumab were consistent with that observed in previous trials
RATIONALE 305 is the sixth positive Phase 3 trial in tislelizumab’s broad clinical program
CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)-- BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced positive findings from the global Phase 3 RATIONALE 305 trial of tislelizumab versus placebo in combination with chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. At the interim analysis, tislelizumab in combination with chemotherapy met the primary endpoint of overall survival (OS) in patients with PD-L1 expression, with additional follow-up needed to assess OS benefits in the intention-to-treat (ITT) population. The safety profile of tislelizumab was consistent with that observed in previous trials, with no new safety signals identified with the addition of chemotherapy.
“The addition of tislelizumab to chemotherapy significantly extended the overall survival for previously untreated patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumor expressed PD-L1. We will continue to follow up to determine OS benefits across the patient population in the trial,” commented Yong (Ben) Ben, M.D., Chief Medical Officer, Solid Tumors at BeiGene.
RATIONALE 305: Tislelizumab vs. Placebo in Combination with Chemotherapy in First-Line G/GEJ Adenocarcinoma
RATIONALE 305 is a randomized, double-blind, placebo-controlled global Phase 3 trial (NCT03777657) comparing the efficacy and safety of tislelizumab combined with platinum and fluoropyrimidine chemotherapy and placebo combined with platinum and fluoropyrimidine chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic G/GEJ adenocarcinoma. The primary endpoint of the trial is OS. Secondary endpoints include progression-free survival (PFS), overall response rate (ORR), duration of response (DoR), and safety. A total of 997 patients from 13 countries and regions globally, including close to 50 percent from outside of China, were enrolled and randomized 1:1 to receive either tislelizumab and chemotherapy or placebo and chemotherapy.
To learn more about BeiGene, please visit www.beigene.com
About Tislelizumab
Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
The China National Medical Products Administration (NMPA) has approved tislelizumab in six indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for second- or third-line treatment of patients with locally advanced or metastatic NSCLC who progressed on prior platinum-based chemotherapy. NMPA also granted conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies, for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, and for the treatment of patients with hepatocellular carcinoma (HCC) who have received at least one systemic therapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.
In addition, three supplemental Biologics License Applications for tislelizumab are under review by the Center for Drug Evaluation (CDE) of the NMPA, including for patients with previously treated, locally advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors, for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have disease progression following or are intolerant to first-line standard chemotherapy, and for first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC).
In the U.S., a Biologics License Application for tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic ESCC after prior systemic therapy is currently under review by the U.S. Food and Drug Administration with a PDUFA target action date of July 12, 2022.
BeiGene has initiated or completed 17 potentially registration-enabling clinical trials in China and globally, including 13 Phase 3 trials and four pivotal Phase 2 trials.
In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize tislelizumab in North America, Europe, and Japan.
Tislelizumab is not approved for use outside of China.
About the Tislelizumab Clinical Program
Clinical trials of tislelizumab include:
- Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
- Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed or refractory classical Hodgkin Lymphoma (cHL; NCT04486391);
- Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
- Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
- Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
- Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
- Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
- Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
- Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
- Phase 2 trial in patients with locally advanced or metastatic urothelial bladder cancer (NCT04004221);
- Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
- Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
- Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
- Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
- Phase 2 trial of tislelizumab in patients with relapsed or refractory cHL (NCT03209973);
- Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
- Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).
View source version on businesswire.com: https://www.businesswire.com/news/home/20220124005223/en/
Source: BeiGene
BeiGene reports positive findings from Phase 3 trial of tislelizumab + chemotherapy in gastric cancer
Jan. 24, 2022 6:10 AM ETBeiGene, Ltd. (BGNE)By: Mamta Mayani, SA News Editor
- BeiGene (NASDAQ:BGNE) announces positive findings from the Phase 3 RATIONALE 305 trial of tislelizumab versus placebo in combination with chemotherapy as a first-line treatment for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
- https://seekingalpha.com/news/3790546-beigene-reports-positive-findings-from-phase-3-trial-of-tislelizumab-chemotherapy-in-gastric-cancer
- https://seekingalpha.com/symbol/BGNE
- https://www.beigene.com/en-us/science-and-product-portfolio/pipeline/tislelizumab
Eltanexor (KPT-8602)
Karyopharm Receives Orphan Drug Designation from FDA for Eltanexor for the Treatment of Myelodysplastic Syndromes
NEWTON, Mass., Jan. 24, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for eltanexor, a novel oral, Selective Inhibitor of Nuclear Export (SINE) compound, for the treatment of myelodysplastic syndromes (MDS). MDS are a group of diseases characterized by ineffective production of the components of the blood due to poor bone marrow function with a risk of progression to acute myeloid leukemia.
Karyopharm is currently investigating eltanexor in an ongoing open-label Phase 1/2 study as a single-agent or in combination with approved and investigational agents in patients with several types of hematologic and solid tumor cancers (KCP-8602-801; NCT02649790). Previously, Karyopharm reported positive data from an investigator-sponsored Phase 1 study evaluating single-agent eltanexor in patients with hypomethylating agent (HMA)-refractory MDS, where eltanexor demonstrated a 53% overall response rate and median overall survival of 9.9 months. This compares favorably to historical survival of four to six months for HMA-refractory MDS patients.
Approximately 15,000 people are diagnosed with intermediate-to-high risk MDS each year in the U.S.1 HMAs are the current standard of care for newly diagnosed, higher-risk MDS patients. However, only 40-60% of patients respond, with these responses typically lasting less than two years.2 The prognosis in HMA-refractory disease is poor, with a median overall survival of four to six months.3,4 There are currently no approved therapies for HMA- refractory MDS.
"We are pleased to receive the FDA's orphan drug designation for eltanexor in MDS and believe it reinforces eltanexor's potential to improve clinical outcomes for patients with HMA-refractory MDS," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "We are focused on advancing our ongoing clinical trials and remain steadfast in our commitment to bringing this new treatment option to patients and their families."
Orphan drug designation by the FDA is granted to promote the development of drugs that target conditions affecting 200,000 or fewer U.S. patients annually and are expected to provide a significant therapeutic advantage over existing treatments. Orphan designation qualifies a company for certain incentives that apply across all stages of drug development, including the potential for seven years of market exclusivity following marketing approval, tax credits on qualified U.S. clinical trials, eligibility for orphan drug grants, and exemption from certain administrative fees.
About Eltanexor
Eltanexor (KPT-8602) is an investigational novel SINE compound that, like selinexor, functions by binding with, and inhibiting, the nuclear export protein, XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells.
In preclinical models, eltanexor has a broad therapeutic window with minimal penetration of the blood brain barrier and, therefore, has the potential to serve as another SINE compound for cancer indications. Following oral administration, animals treated with eltanexor show lower percentage of body weight loss and improved food consumption than animals similarly treated with selinexor. This allows more frequent dosing of eltanexor, enabling a longer period of exposure than is possible with selinexor.
Eltanexor is an investigational medicine and has not been approved by the United States Food and Drug Administration or any other regulatory agency.
For more information about our people, science and pipeline, please visit www.karyopharm.com, and follow us on Twitter at @Karyopharm and LinkedIn.
XPOVIO® and NEXPOVIO® are registered trademarks of Karyopharm Therapeutics Inc. Any other trademarks referred to in this release are the property of their respective owners.
Karyopharm wins FDA’s orphan drug status for eltanexor in myelodysplastic syndromes
Jan. 24, 2022 7:16 AM ET
Karyopharm Therapeutics Inc. (KPTI)
By: Dulan Lokuwithana, SA News Editor1 Comment
- Karyopharm Therapeutics (NASDAQ:KPTI) is trading ~2.9% higher in the pre-market after announcing that the FDA granted the orphan drug designation for its experimental oral medication, eltanexor, for the treatment of myelodysplastic syndromes (MDS).
- https://seekingalpha.com/news/3790577-karyopharm-wins-fdas-orphan-drug-status-for-eltanexor-in-myelodysplastic-syndromes
- https://seekingalpha.com/symbol/KPTI
- https://www.karyopharm.com/pipeline/oral-eltanexor/
SKYRIZI® (risankizumab-rzaa)
January 21, 2022
U.S. FDA Approves Second Indication for SKYRIZI® (risankizumab-rzaa) to Treat Adults with Active Psoriatic Arthritis
- SKYRIZI® (risankizumab-rzaa) met the primary endpoint of ACR20 at week 24 in two pivotal studies, demonstrating significant improvement in joint symptoms, including swollen, tender and painful joints, compared to placebo[1,2,3]
- SKYRIZI also showed improvement in dactylitis and enthesitis - inflammation of fingers, toes and sites at which tendons or ligaments attach to bone[1,2,3]
- SKYRIZI is now the only IL-23 inhibitor approved for adults with moderate to severe plaque psoriasis and active psoriatic arthritis that can be administered with a single injection four times a year (after two starter doses at weeks 0 and 4)[1]
NORTH CHICAGO, Ill., Jan. 21, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for the treatment of adults with active psoriatic arthritis (PsA), a systemic inflammatory disease that affects the skin and joints and impacts approximately 30 percent of patients with psoriasis.1,4-7
The FDA approval is supported by data from two pivotal studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated the efficacy and safety of SKYRIZI in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying antirheumatic drugs (DMARDs).2,3 Across the two Phase 3 studies, SKYRIZI met the primary endpoint of ACR20 response at week 24 compared to placebo and demonstrated significant improvements across several other manifestations of PsA, including swollen, tender and painful joints.2,3
"Patients often do not suspect a connection between their psoriasis skin symptoms and the joint pain, swelling and stiffness they may be experiencing, potentially leading to a delay in diagnosis and treatment of psoriatic arthritis," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "We're proud to expand the use of SKYRIZI to patients with psoriatic arthritis who are living with the debilitating combination of skin and joint symptoms."
SKYRIZI maintains a dosing regimen for PsA that is consistent with the existing regimen for moderate to severe plaque psoriasis patients – a single 150 mg subcutaneous injection four times a year (after two starter doses at weeks 0 and 4) – and can be administered alone or in combination with DMARDs.1
"In the pivotal KEEPsAKE trials, SKYRIZI demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis and dactylitis," said Alan J. Kivitz, M.D., CPI, founder and medical director of the Altoona Center for Clinical Research and Altoona Arthritis and Osteoporosis Center in Duncansville, Pa. and KEEPsAKE clinical trial investigator. "This approval provides both dermatologists and rheumatologists with an option that helps improve skin and joint symptoms in patients with active psoriatic arthritis, alongside a quarterly dosing schedule that may fit their patients' lifestyle."
SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally.
Highlights from the Pivotal Phase 3 Program1,2,3
- In KEEPsAKE-1 and KEEPsAKE-2, 57.3 percent and 51.3 percent of patients receiving SKYRIZI achieved the primary endpoint of ACR20 response at week 24, respectively, versus 33.5 percent and 26.5 percent receiving placebo. SKYRIZI also demonstrated improvements in ACR50 and ACR70 responses compared to placebo at week 24.
- SKYRIZI showed improvements in other key manifestations of PsA compared to placebo at week 24, including improvements in dactylitis and enthesitis for patients with pre-existing dactylitis and enthesitis.
- Patients with coexistent plaque psoriasis receiving SKYRIZI saw improvements in the skin lesions of psoriasis, compared to placebo, as measured by the Psoriasis Area Severity Index (PASI 90) at week 24.
- SKYRIZI showed a statistically significant improvement in physical function, compared to placebo, as measured by the Health Assessment Questionnaire-Disability Index at week 24, with a mean difference of 0.20 in KEEPsAKE-1 and 0.16 in KEEPsAKE-2.
About KEEPsAKE-1 and KEEPsAKE-22,3
KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of SKYRIZI in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated SKYRIZI in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated SKYRIZI in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomized to SKYRIZI 150 mg or placebo followed by SKYRIZI 150 mg at week 24 in the open-label extension. Patients randomized to SKYRIZI received four maintenance doses a year, following two initiation doses.
The primary endpoint for both studies was the achievement of ACR20 response at week 24. Some of the ranked secondary endpoints included change from baseline in Health Assessment Questionnaire-Disability Index and the achievement of PASI 90 at week 24. The studies are ongoing, and patients in the long-term extension remain blinded to the original randomized allocation for the duration of the study, which will evaluate the long-term safety, tolerability and efficacy of SKYRIZI in patients who have completed the placebo-controlled period.
More information on these trials can be found on www.clinicaltrials.gov (KEEPsAKE-1: NCT03675308; KEEPsAKE-2: NCT03671148).
About SKYRIZI® (risankizumab-rzaa)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.8 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.8 SKYRIZI is approved in the U.S. to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, as well as to treat active psoriatic arthritis in adults. The approved dose for SKYRIZI is 150 mg (one 150 mg pre-filled pen or pre-filled syringe) administered by subcutaneous injection at weeks 0 and 4, and every 12 weeks thereafter. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.9-17
For more information about AbbVie, please visit us at www.abbvie.com.
AbbVie announces FDA approval for Skyrizi in psoriatic arthritis
Jan. 21, 2022 5:06 PM ET AbbVie Inc. (ABBV)
By: Dulan Lokuwithana, SA News Editor13 Comments
- The FDA has approved Skyrizi (risankizumab-rzaa) for adults with active psoriatic arthritis ((PsA)), making it the second indicationfor the IL-23 inhibitor in the U.S., the developer, AbbVie (NYSE:ABBV), announced Friday.
- https://seekingalpha.com/news/3790465-abbvie-announces-fda-approval-for-skyrizi-in-psoriatic-arthritis
- https://seekingalpha.com/symbol/ABBV
- https://www.skyrizi.com/
IMFINZI® (durvalumab) plus tremelimumab
IMFINZI® (durvalumab) plus tremelimumab demonstrated unprecedented survival in 1st-line unresectable liver cancer with 31% of patients alive at three years
PUBLISHED18 January 2022
A single priming dose of tremelimumab plus IMFINZI every four
weeks reduced risk of death by 22% in HIMALAYA Phase III trial
Combination also showed no increase in severe liver toxicity and fewer
discontinuations due to treatment-related adverse events vs. sorafenib
Positive results from the HIMALAYA Phase III trial showed a single priming dose of tremelimumab added to IMFINZI® (durvalumab) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus sorafenib as a 1st-line treatment for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localized treatment.
This novel dose and schedule of IMFINZI and tremelimumab, an anti-CTLA4 antibody, is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab). Results from the trial will be presented on January 21 at the 2022 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium.
Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide.1,2 Approximately 80,000 people in the US, Europe and Japan and 260,000 people in China present with advanced, unresectable HCC each year.3 Only 7% of patients with advanced disease survive five years.4
Ghassan Abou-Alfa, MD, MBA, Attending Physician at Memorial Sloan Kettering Cancer Center and principal investigator in the HIMALAYA Phase III trial, said: “Patients with unresectable liver cancer face a dismal prognosis, and new treatment options are critical to improving long-term survival. The three-year overall survival rate and favorable safety profile seen with the STRIDE regimen set a new benchmark in this setting and underscore the potential of this innovative treatment approach.”
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “The HIMALAYA trial reinforces our scientific approach for tremelimumab, tapping into the potential of CTLA-4 inhibition and a unique dosing regimen to prime the immune system to help patients live longer and with minimal side effects. We look forward to bringing potential new treatment options to patients with unresectable liver cancer, an area of high unmet need, as quickly as possible.”
Patients treated with the STRIDE regimen experienced a 22% reduction in the risk of death versus sorafenib (based on a hazard ratio [HR] of 0.78, 96.02% confidence interval [CI] 0.65-0.93; p=0.0035). Median OS was 16.4 months versus 13.8 for sorafenib. An estimated 31% of patients were still alive at three years versus 20% for sorafenib.
Results also showed an increase in objective response rate (ORR) with the STRIDE regimen versus sorafenib (20.1% vs. 5.1%). Median duration of response (DoR) was 22.3 months with the STRIDE regimen versus 18.4 with sorafenib. The addition of tremelimumab to IMFINZI did not increase severe liver toxicity, and no bleeding risk was observed.
HIMALAYA also tested IMFINZI monotherapy, which demonstrated non-inferior OS to sorafenib (HR 0.86; 95.67% CI 0.73-1.03; non-inferiority margin 1.08) with a median OS of 16.6 months versus 13.8, and an improved tolerability profile versus sorafenib.
Indications:
IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Please see complete Prescribing Information, including Medication Guide.
About IMFINZI® (durvalumab)
IMFINZI is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.
IMFINZI is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiation therapy and is the global standard of care in this setting based on the PACIFIC Phase III trial.
IMFINZI is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small cell lung cancer (ES-SCLC) based on the CASPIAN Phase III trial.
IMFINZI is also approved for previously treated patients with advanced bladder cancer in several countries. Since the first approval in May 2017, more than 100,000 patients have been treated with IMFINZI.
As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with NSCLC, SCLC, bladder cancer, HCC, biliary tract cancer (BTC), esophageal cancer, gastric and gastroesophageal cancer, cervical cancer, ovarian cancer, endometrial cancer, and other solid tumors.
About tremelimumab
Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death.
Tremelimumab is being tested in a clinical trial program in combination with IMFINZI in NSCLC, SCLC, bladder cancer and liver cancer.
For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.
AstraZeneca's Imfinzi + CTLA-4 inhibitor improves survival as liver cancer treatment
Jan. 18, 2022 6:29 PM ET AstraZeneca PLC (AZN) By: Jonathan Block, SA News Editor
- The combination of AstraZeneca's (NASDAQ:AZN) Imfinzi (durvalumab) + the company's experimental CTLA-4 inhibitor tremelimumab led to a clinically meaningful improvement in overall survival ("OS") versus Nexavar (sorafenib) as a first-line unresectable hepatocellular carcinoma treatment.
- https://seekingalpha.com/news/3789019-astrazeneca-imfinzi-ctla-4-inhibitor-improves-survival-as-liver-cancer-treatment
- https://seekingalpha.com/symbol/AZN
- https://www.imfinzi.com/
NGENLA® (Somatrogon)
Japan’s MHLW Approves Pfizer and OPKO’s NGENLA® (Somatrogon), a New Long-Acting Treatment for Pediatric Growth Hormone Deficiency
Download as PDFJanuary 20, 2022
NGENLA® offers a new once-weekly treatment option for children living with growth hormone deficiency
TOKYO and MIAMI, Jan. 20, 2022 (GLOBE NEWSWIRE) -- Pfizer Japan Inc. and OPKO Health, Inc. (NASDAQ: OPK) announced today that the next generation long-acting growth hormone injection, NGENLA® (somatrogon) Inj. 24 mg Pens and 60 mg Pens, has been approved by the Ministry of Health, Labour and Welfare (MHLW) in Japan. NGENLA® is a once-weekly long-acting recombinant human growth hormone, for the indication of short statue due to growth hormone deficiency without closed epiphyses. NGENLA® provides patients with pediatric growth hormone deficiency (GHD) with a new option that reduces treatment frequency from daily injections to once-weekly injections.
This approval is based on the results of a Phase 3 study conducted in Japanese subjects and a global Phase 3 clinical study, both of which were conducted in subjects with pediatric GHD, and both of which compared the efficacy and safety of once-weekly NGENLA® with GENOTROPIN® (somatropin), a recombinant human growth hormone for injection administered once-daily. In both studies, NGENLA® showed comparable efficacy to GENOTROPIN in the primary endpoint of annual height velocity at 12 months. NGENLA® was generally well tolerated in both studies, with comparable safety to that of GENOTROPIN administered once-daily with respect to the types, numbers and severity of the adverse events observed between the treatment arms.
“We are pleased to receive approval for once-weekly NGENLA®, which offers a new treatment option for pediatric GHD patients that can help reduce the burden associated with daily growth hormone administration. We wish to express our gratitude to the patients and their families who participated in the clinical studies and to all the sites conducting these trials,” said Taro Ishibashi, President of Pfizer R&D Japan G.K.
In 2014, Pfizer and OPKO Health entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing somatrogon for GHD.
【About NGENLA】
Product nameNGENLA® Inj.24mg Pens
NGENLA® Inj.60mg Pens General nameSomatrogon (recombination)INDICATIONSShort stature due to growth hormone deficiency without closed epiphysesDOSAGE AND ADMINISTRATION
Generally, Somatrogon (recombination) 0.66 mg per kilogram body weight is administered once-weekly by subcutaneous injection.
Marketing
Authorization Holder
Pfizer Japan Inc.
About the Japan Phase 3 Study
The Phase 3 study of NGENLA® in 44 treatment-naïve Japanese pre-pubertal children with pediatric GHD was a 12-month, open-label, randomized, active-controlled, parallel-group study of the efficacy and safety of weekly NGENLA® compared to recombinant human growth hormone (r-hGH), GENOTROPIN (somatropin) for injection treatment administered once-daily. Eligible patients were randomized in a 1:1 ratio to receive either once-weekly NGENLA® or GENOTROPIN administered once-daily (reference therapy, 0.025 mg/kg/day which is equivalent to 0.175 mg/kg/week). To obtain pharmacokinetic information of three different weekly doses in Japanese pediatric GHD patients, NGENLA® treated patients received 0.25 mg/kg/week for 2 weeks, followed by 0.48 mg/kg/week for 2 weeks followed by 0.66 mg/kg/week for the remaining 46 weeks.
About the Global Phase 3 Study
The Global Phase 3 study of NGENLA® in 224 treatment-naïve children with pediatric GHD in over 20 countries was a 12-month randomized, open-label, active-controlled study evaluating the safety and efficacy of weekly NGENLA® (somatrogon) injection compared to GENOTROPIN (somatropin) administered once-weekly. Eligible patients were randomized 1:1 into two arms: somatrogon administered at a dose of 0.66 mg/kg body weight once-weekly vs GENOTROPIN® (somatropin) administered at a dose of 0.034 mg/kg body weight once-daily.
About NGENLA® (somatrogon) injection
NGENLA® is a biologic product that is glycosylated and comprises the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of the molecule. NGENLA® was approved in Canada in October 2021 and in Australia in November 2021.
For more information, visit www.opko.com.
In addition, to learn more, please visit us on www.pfizer.com
Pfizer-OPKO's Ngenla approved in Japan for pediatric growth hormone deficiency
Jan. 20, 2022 11:07 AM ET Pfizer Inc. (PFE), OPK
By: Ravikash, SA News Editor5 Comments
- Pfizer (PFE -0.1%) and OPKO Health's (OPK +1.8%) growth hormone injection Ngenla (somatrogon) was approved in Japan for pediatric growth hormone deficiency.
- https://seekingalpha.com/news/3789727-pfizer-opkos-ngenla-approved-in-japan-for-pediatric-growth-hormone-deficiency
- https://seekingalpha.com/symbol/PFE
- https://seekingalpha.com/symbol/OPK
LUMAKRAS® (SOTORASIB)
LUMAKRAS® (SOTORASIB) RECEIVES APPROVAL IN JAPAN FOR PATIENTS WITH KRAS G12C-MUTATED ADVANCED NON-SMALL CELL LUNG CANCER
Approval Based on Pivotal CodeBreaK 100 Data Demonstrating Durable Responses and a Favorable Benefit-Risk Profile With LUMAKRAS
LUMAKRAS is the Only KRAS G12C Inhibitor Approved Anywhere in the World
THOUSAND OAKS, Calif., Jan. 20, 2022 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that LUMAKRAS® (sotorasib) has been approved in Japan for the treatment of KRAS G12C-mutated positive, unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC) that has progressed after systemic anticancer therapy.
"Today's approval of LUMAKRAS as the first and only KRASG12C inhibitor marks a paradigm shift in the treatment of patients with non-small cell lung cancer in Japan," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "In just over three years since the first patient was dosed in the pivotal CodeBreaK 100 trial, LUMAKRAS is now approved in nearly 40 countries, illustrating our commitment to accelerating transformative medicines for patients living with cancers that have yet to be fully addressed."
The approval by the Japan Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the Phase 2 CodeBreaK 100 clinical trial in NSCLC, the largest trial conducted to date for patients with the KRAS G12C mutation. Based on the approved label in Japan, LUMAKRAS 960 mg, orally administered once-daily, demonstrated an objective response rate (ORR) of 37% (95% CI: 28.8-46.6) in 123 evaluable patients (including 10 Japanese patients* with a data cutoff date: Sept. 1, 2020). Adverse reactions were observed in 128 (67%) of 190 patients† (including 13 Japanese patients). The most common adverse reactions (incidence ≥ 5%) were diarrhea (28%), nausea, increased alanine aminotransferase (ALT) and increased aspartate aminotransferase (AST) (16% each), fatigue (11%), increased blood alkaline phosphatase (8%), vomiting (7%) and abdominal pain (5%).
Results from the Phase 2 CodeBreaK clinical trial in NSCLC were published in The New England Journal of Medicine.
"KRAS gene mutations are one of the oldest known cancer driver gene mutations," said Steve Sugino, president and representative director, Amgen K.K. "However, it has proven to be very difficult to develop drugs for the treatment of KRAS gene mutations. For nearly 40 years, researchers have said that the mutation was 'undruggable.' I am very pleased that LUMAKRAS is now approved as a new treatment option for patients in Japan."
"The prognosis for patients with non-small cell lung cancer who have distant metastases or whose disease has relapsed after surgery, is generally poor," said Tetsuya Mitsudomi, M.D., professor, Department of Surgery, Division of Thoracic Surgery at Kindai University School of Medicine, past-president of the International Association for the Study of Lung Cancer (IASLC) and past-president of the Japan Lung Cancer Society (JLCS). "Recent developments in molecular-targeted drugs and immunotherapy have dramatically improved the prognosis for these patients. However, despite the relatively high frequency of the KRAS G12C mutation, no drugs specifically targeting this mutation have been available until recently. Therefore, the approval of LUMAKRAS in Japan is a major milestone in the treatment of non-small cell lung cancer patients with KRAS G12C mutations."
On March 11, 2021, the MHLW designated sotorasib as an orphan drug.
*3 subjects (including 1 Japanese subject) without measurable lesions at baseline as determined by the central review were excluded.
†Patients with non-small cell lung cancer who received at least 1 dose of this drug 960 mg in the phase I and II parts.
About LUMAKRAS®/LUMYKRAS® (sotorasib)
Amgen took on one of the toughest challenges of the last 40 years in cancer research by developing LUMAKRAS/LUMYKRAS, a KRASG12C inhibitor.1 LUMAKRAS/LUMYKRAS has demonstrated a positive benefit-risk profile with rapid, deep and durable anticancer activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation.2
Amgen is progressing the largest and broadest global KRASG12C inhibitor development program with unparalleled speed and exploring more than 10 sotorasib combination regimens, including triplets, with clinical trial sites spanning five continents. To date, over 4,000 patients around the world have received LUMAKRAS/LUMYKRAS through the clinical development program and commercial use.
In May 2021, LUMAKRAS was the first KRASG12C inhibitor to receive regulatory approval anywhere in the world with its approval in the U.S., under accelerated approval. LUMAKRAS/LUMYKRAS® is also approved in the United Arab Emirates, the European Union and Switzerland, and in Canada and Great Britain under the FDA's Project Orbis. Through Project Orbis, Amgen also has Marketing Authorization Applications (MAAs) for sotorasib in review in Australia, Brazil, Singapore and Israel. Additionally, Amgen has submitted MAAs in South Korea, Turkey, Taiwan, Colombia, Thailand, Mexico, Hong Kong, Saudi Arabia, Argentina, Kuwait and Qatar.
LUMAKRAS/LUMYKRAS is also being studied in multiple other solid tumors.3
About CodeBreaK
The CodeBreaK clinical development program for Amgen's drug sotorasib is designed to study patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.
CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors.2,3 Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline.2 The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and results have been published.11
CodeBreaK 200, the global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in KRAS G12C-mutated NSCLC completed enrollment of 345 patients. Eligible patients had previously treated, locally-advanced and unresectable or metastatic KRAS G12C-mutated NSCLC. The primary endpoint is progression-free survival and key secondary endpoints include overall survival, objective response rate, and patient-reported outcomes.
Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment. A Phase 2 randomized study will evaluate sotorasib in patients with stage IV KRAS G12C-mutated NSCLC in need of first-line treatment (CodeBreaK 201).
For information, please visit www.hcp.codebreaktrials.com.
LUMAKRAS® (sotorasib) U.S. Indication
LUMAKRAS is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Please see LUMAKRAS full Prescribing Information.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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SOURCE Amgen
Amgen's LUMAKRAS approved in Japan for the treatment of non-small cell lung cancer patients with KRAS G12C mutations
Jan. 20, 2022 5:57 AM ETAmgen Inc. (AMGN)By: Niloofer Shaikh, SA News Editor
- Amgen (NASDAQ:AMGN) announced that LUMAKRAS (sotorasib) has been approved by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of KRAS G12C-mutated positive, unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC) that has progressed after systemic anticancer therapy.
- https://seekingalpha.com/news/3789506-amgens-lumakras-approved-in-japan-for-the-treatment-of-non-small-cell-lung-cancer-patients-with-kras-g12c-mutations
- https://seekingalpha.com/symbol/AMGN
- https://www.lumakras.com/
- https://www.amgen.com/
LIBTAYO® (CEMIPLIMAB-RWLC) IN COMBINATION WITH CHEMOTHERAPY
January 19, 2022 at 7:00 AM EST Back
FDA ACCEPTS FOR REVIEW LIBTAYO® (CEMIPLIMAB-RWLC) IN COMBINATION WITH CHEMOTHERAPY FOR FIRST-LINE TREATMENT OF ADVANCED NSCLC
TARRYTOWN, N.Y., Jan. 19, 2022 /PRNewswire/ --
Regulatory filing recently submitted in the European Union
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo® (cemiplimab-rwlc) in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer (NSCLC). The target action date for the FDA decision is September 19, 2022.
The sBLA is supported by results from a randomized, multicenter Phase 3 trial that investigated Libtayo in combination with a physician's choice of platinum-doublet chemotherapy (Libtayo combination), compared to platinum-doublet chemotherapy alone. Enrolled patients (n=466) had locally advanced or metastatic NSCLC, irrespective of PD-L1 expression level or tumor histology, and with no ALK, EGFR or ROS1 aberrations. A regulatory filing has also been recently submitted to the European Medicines Agency.
The Phase 3 trial supporting the sBLA was stopped early after the Libtayo combination demonstrated a significant overall survival improvement compared to chemotherapy alone. Results were presented at the European Society for Medical Oncology Virtual Congress in 2021. Among patients in the Libtayo combination (n=312) and chemotherapy alone (n=154) groups, treatment discontinuations due to adverse events (AEs) occurred in 5% and 3% of patients, respectively. Immune-mediated AEs occurred in 19% of patients in the Libtayo combination group.
Notably, the Phase 3 trial was designed to include baseline characteristics seen in everyday clinical practice. Among those enrolled, 43% had tumors with squamous histology, 67% had tumors with <50% PD-L1 expression, 15% had inoperable locally advanced disease not eligible for definitive chemoradiation, and 7% had pretreated and clinically stable brain metastases. In addition, 84% of patients had an ECOG 1 performance status, which indicates the presence of cancer-related symptoms. ECOG performance status assesses patient ability to conduct daily living activities and prognosis on a scale of increasing severity ranging from 0 (no symptoms) to 5 (death).
In 2021, Libtayo was approved in the U.S. and European Union as first-line monotherapy treatment for adult patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK or ROS1 aberrations.
Libtayo, which was invented using Regeneron's proprietary VelocImmune® technology, is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. The use of Libtayo in combination with chemotherapy for advanced NSCLC is investigational, and its safety and efficacy have not been fully evaluated by any regulatory authority.
About Libtayo
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. Libtayo is indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma, and advanced NSCLC.
The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
U.S. FDA-approved Indications
Libtayo is a prescription medicine used to treat people with:
- A type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.
- A type of skin cancer called basal cell carcinoma (BCC):
- That cannot be removed by surgery (locally advanced BCC) and have received treatment with a hedgehog inhibitor (HHI), or cannot receive treatment with an HHI.
- That has spread (metastatic BCC) and have received treatment with an HHI, or cannot receive treatment with an HHI. This use is approved based on how many patients responded to treatment and how long they responded. Studies are ongoing to provide additional information about clinical benefit.
- A type of lung cancer called non-small cell lung cancer (NSCLC). Libtayo may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high "PD-L1" and your tumor does not have an abnormal "EGFR", "ALK" or "ROS1" gene.
It is not known if Libtayo is safe and effective in children.
Please see full Prescribing Information, including Medication Guide.
For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
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SOURCE Regeneron Pharmaceuticals, Inc.
Sanofi-Regeneron's Libtayo combo accepted for review by FDA for lung cancer subtype
Jan. 19, 2022 11:52 AM ET Regeneron Pharmaceuticals, Inc. (REGN)SNY By: Ravikash, SA News Editor
- The U.S. Food and Drug Administration (FDA) accepted to review Regeneron Pharmaceuticals (REGN +1.9%) and Sanofi's (SNY -0.2%) application seeking approval of Libtayo (cemiplimab-rwlc) in combination with chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC).
- https://seekingalpha.com/news/3789265-sanofi-regenerons-libtayo-combo-accepted-for-review-by-fda-for-lung-cancer-subtype
https://seekingalpha.com/symbol/SNY
https://seekingalpha.com/symbol/REGN
BRUKINSA (zanubrutinib)
BeiGene Announces Acceptance of a Supplemental New Drug Application in China for BRUKINSA (zanubrutinib) in Waldenström’s Macroglobulinemia
Jan 20, 2022 5:00 AM
BRUKINSA received the China NMPA approval for the treatment of patients with relapsed or refractory Waldenström’s macroglobulinemia (WM) in June 2021
The submission, supported by the ASPEN trial results, could potentially expand BRUKINSA to front-line care of WM
CAMBRIDGE, Mass., & BEIJING--(BUSINESS WIRE)-- BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) for BeiGene’s BTK inhibitor BRUKINSA® (zanubrutinib) as a treatment for adult patients with Waldenström’s macroglobulinemia (WM).
“The sNDA acceptance is welcoming news, and following BRUKINSA’s recent NMPA approval for patients with WM in the relapsed or refractory setting, this represents an opportunity to expand access to more WM patients in China, subject to NMPA approval. As demonstrated in the ASPEN trial, BRUKINSA can offer an efficacious treatment option with improved safety in regard to certain cardiovascular events, such as atrial fibrillation, for patients with WM,” commented Jane Huang, M.D., Chief Medical Officer, Hematology, BeiGene. “The ASPEN trial has supported BRUKINSA’s approval for patients with WM in the U.S., Canada, Australia, and the European Union. We look forward to continued discussions with the CDE and the opportunity to bring this potential best-in-class therapy to more people in the WM community in China.”
The sNDA is supported by clinical results from the randomized, open-label, multicenter Phase 3 ASPEN trial (NCT03053400) comparing BRUKINSA to ibrutinib in patients with relapsed or refractory (R/R) or treatment-naïve (TN) WM.
As assessed by an independent review committee (IRC) based on the modified Sixth International Workshop on Waldenström’s Macroglobulinemia (IWWM-6) response criteria (Treon 2015), the combined rate of complete response (CR) and very good partial response (VGPR) in the overall intention-to-treat (ITT) population was 28% with BRUKINSA (95% CI: 20, 38), compared to 19% with ibrutinib (95% CI: 12, 28). While this difference was not statistically significant (p=0.09), BRUKINSA did achieve numerically higher VGPR rates and trends towards increased response quality.1
In the ASPEN trial, BRUKINSA demonstrated a more favorable safety profile compared to ibrutinib with lower frequency of certain adverse events, including atrial fibrillation or flutter (2% vs. 15%) and major hemorrhage (6% vs. 9%). Of the 101 patients with WM treated with BRUKINSA, 4% of patients discontinued due to adverse events, and adverse events leading to dose reduction occurred in 14% of patients.4
About Waldenström’s Macroglobulinemia
Waldenström’s macroglobulinemia is a rare, slow-growing lymphoma, characterized by bone marrow infiltration with monoclonal immunoglobulin M (IgM) secreting lymphoplasmacytic cells, that occurs in less than two percent of patients with non-Hodgkin’s lymphoma (NHL).1 The disease usually affects older adults and is primarily found in the bone marrow, although it may also impact lymph nodes and the spleen.2 In China, there are an estimated 88,200 patients diagnosed with lymphoma each year. Approximately 91% of these cases are classified as NHL, amounting to ~1,000 newly diagnosed WM patients per year in China.3
About BRUKINSA
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.
BRUKINSA is approved in the following indications and regions:
- For the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy (United States, November 2019)*;
- For the treatment of MCL in adult patients who have received at least one prior therapy (China, June 2020)**;
- For the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have received at least one prior therapy (China, June 2020)**;
- For the treatment of MCL in patients who have received at least one prior therapy (Israel, January 2021);
- For the treatment of relapsed or refractory MCL (United Arab Emirates, February 2021);
- For the treatment of Waldenström’s macroglobulinemia (WM) in adult patients (Canada, March 2021);
- For the treatment of adult patients with WM who have received at least one prior therapy (China, June 2021)**;
- For the treatment of MCL in adult patients who have received at least one prior therapy (Canada, July 2021);
- For the treatment of MCL in adult patients who have received at least one prior therapy (Chile, July 2021);
- For the treatment of adult patients with MCL who have received at least one previous therapy (Brazil, August 2021);
- For the treatment of adult patients with WM (United States, August 2021);
- For the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen (United States, September 2021)*;
- For the treatment of adult patients with MCL who have received at least one previous therapy (Singapore, October 2021);
- For the treatment of adult patients with WM who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy (Australia, October 2021);
- For the treatment of adult patients with MCL who have received at least one prior therapy (Australia, October 2021);
- For the treatment of adult patients with MCL who have received at least one previous therapy (Russia, October 2021);
- For the treatment of adult patients with MCL who have received at least one previous therapy (Saudi Arabia, November 2021);
- For the treatment of adult patients with WM who have received at least one prior therapy or first-line treatment of patients unsuitable for chemo-immunotherapy (European Union plus Iceland, Lichtenstein, and Norway, November 2021);
- For the treatment of eligible adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or for the first-line treatment of eligible patients unsuitable for chemo-immunotherapy (Great Britain, December 2021); and
- For the treatment of adult patients with MCL who have received at least one previous therapy (Ecuador, December 2021).
To date, more than 20 marketing authorization applications have been submitted for BRUKINSA for various indications..
* This indication was approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
** This indication was approved under conditional approval. Complete approval for this indication may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.
Please see full U.S. Prescribing Information at www.beigene.com/PDF/BRUKINSAUSPI.pdf and Patient Information at www.beigene.com/PDF/BRUKINSAUSPPI.pdf.
To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220120005178/en/
Source: BeiGene
BeiGene receives approval of supplemental new drug application for BRUKINSA in China
Jan. 20, 2022 5:41 AM ET
By: Niloofer Shaikh, SA News Editor
- BeiGene (NASDAQ:BGNE) announced that the Center for Drug Evaluation of the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application ((sNDA)) for BeiGene’s BTK inhibitor BRUKINSA (zanubrutinib) as a treatment for adult patients with Waldenström’s macroglobulinemia (WM).
- https://seekingalpha.com/news/3789503-beigene-receives-approval-of-supplemental-new-drug-application-for-brukinsa-in-china
- https://seekingalpha.com/symbol/BGNE
- https://www.brukinsa.com/
- https://www.beigene.com/
cabozantinib (CABOMETYX®) in combination with immunotherapies
Exelixis Announces Detailed Results for Cabozantinib in Combination with Immunotherapies in Patients with Advanced Colorectal Cancer at ASCO GI 2022PDF Version
– Cabozantinib in combination with atezolizumab evaluated in cohort 16 of the phase 1b COSMIC-021 trial demonstrated encouraging clinical activity with a manageable safety profile in patients with previously treated metastatic colorectal cancer –
– Cabozantinib in combination with durvalumab evaluated in cohort 2 of the phase 2 CAMILLA trial demonstrated promising efficacy and was generally well tolerated with no new safety signals in chemotherapy-refractory patients with advanced mismatch repair proficient/micro satellite stable colorectal cancer –
ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 18, 2022-- Exelixis, Inc. (Nasdaq: EXEL) today announced results for cabozantinib (CABOMETYX®) in combination with immunotherapies in patients with advanced colorectal cancer, including encouraging data from cohort 16 of the phase 1b COSMIC-021 trial of cabozantinib in combination with atezolizumab in patients with metastatic colorectal cancer who were previously treated with fluoropyrimidine-containing chemotherapy. Results from cohort 2 of the phase 2 CAMILLA trial of cabozantinib in combination with durvalumab in patients with advanced mismatch repair proficient/micro satellite stable (pMMR/MSS) colorectal cancer patients who were chemotherapy-refractory were also announced. The data from these studies are being presented during Poster Session C: Cancers of the Colon, Rectum, and Anus on Saturday, January 22 at the 2022 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI).
Abstract 121: A phase 1b multi-tumor cohort study of cabozantinib plus atezolizumab in advanced solid tumors (COSMIC-021): Results of the colorectal cancer cohort
At a median follow-up of 28.1 months, the primary endpoint of objective response rate (ORR) by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in cohort 16 (n=31) was 10%. The disease control rate (DCR; complete response + partial response + stable disease) was 71%. Median progression-free survival (PFS) was 3.0 months (95% confidence interval [CI]: 2.7-5.4), and median overall survival (OS) was 14.0 months (95% CI: 5.5-16.7). Median duration of response was 7.6 months (95% CI: 4.2-not estimable [NE]).
A post-hoc exploratory analysis showed that patients with wild-type RAS (n=12) had longer PFS and OS compared with patients with RAS mutations (n=19): median PFS was 5.8 months (95% CI: 2.8-11.0) compared with 2.7 months (95% CI: 1.6-4.1), respectively, and median OS was 16.7 months (95% CI: 8.4-NE) compared with 8.7 months (95% CI: 4.7-15.9), respectively. ORR was 25% for patients with wild-type RAS and 0% for patients with RAS mutations.
Abstract 135: Phase II trial of cabozantinib (Cabo) plus durvalumab (Durva) in chemotherapy refractory patients with advanced mismatch repair proficient/microsatellite stable (pMMR/MSS) colorectal cancer (CRC): CAMILLA CRC cohort results
Of the 36 patients enrolled in cohort 2 of the CAMILLA trial, 29 were evaluable for the efficacy analysis. The primary outcome of investigator-assessed ORR per modified RECIST version 1.1 was 27.6%. The confirmed partial response rate was 20.7%, and the DCR was 86.2%. Median PFS was 3.8 months (95% CI: 3.4-6.3), with a 6-month PFS of 34.5% (95% CI: 17.9-54.3). Median OS was 9.1 months (95% CI: 5.8-21.8). In a subgroup analysis of those with wild-type RAS (n=12), ORR was 50.0%, and DCR was 83.3%. Median PFS was 6.3 months (95% CI: 1.8-NE), and median OS was 21.8 months (95% CI: 4.5-NE).
Patients eligible for CAMILLA cohort 2 had advanced pMMR/MSS colorectal cancer and had progressed on two or more lines of therapy. Ninety percent of patients had an ECOG Performance Score of 1, 41% had wild-type RAS and 79% had liver metastases. Approximately half (52%) of patients had received at least three prior lines of therapy.
Mismatch repair status and microsatellite instability status are considered prognostic factors in colorectal cancer and can impact treatment decisions.1 Patients with metastatic colorectal cancer who have microsatellite stable and/or mismatch repair-proficient tumors tend to have poor responses to immune checkpoint inhibitor monotherapy, meaning alternative treatment strategies are needed.2, 3
Among the 36 patients evaluable for safety, the most common treatment-related AEs were grade 1/2 fatigue (53%), nausea (42%), diarrhea (36%), anorexia (31%) and hand-foot syndrome (25%). Eleven patients (31%) experienced grade 3 or higher treatment-related AEs. Grade 3 or higher immune-related AEs occurred in 16.6% of patients. One patient discontinued durvalumab due to AEs; no patients discontinued cabozantinib.
CAMILLA is an investigator-sponsored trial conducted by Anwaar Saeed, M.D., GI medical oncologist and Associate Director of the Early Phase Program at The University of Kansas Cancer Center.
“After disease progression following prior treatment, people with advanced colorectal cancer are in need of additional treatment options that can help control their disease,” said Vicki L. Goodman, M.D., Executive Vice President, Product Development and Medical Affairs, and Chief Medical Officer, Exelixis. “We are pleased that the findings from cohort 16 of COSMIC-021 and cohort 2 of CAMILLA validate the potential of cabozantinib in combination with immunotherapies in advanced colorectal cancer, as this patient community often faces poor outcomes.”
About COSMIC-021
COSMIC-021 is a multicenter, phase 1b, open-label study that is divided into two parts: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase was designed to enroll patients either with advanced renal cell carcinoma (RCC) with or without prior systemic therapy or with inoperable, locally advanced, metastatic or recurrent urothelial carcinoma (UC), (including renal, pelvis, ureter, urinary bladder and urethra) after prior platinum-based therapy. Ultimately, all 12 patients who enrolled in this stage of the trial were patients with advanced RCC. The dose-escalation phase of the study determined the recommended dose of cabozantinib to be 40 mg daily when given in combination with atezolizumab (1200 mg infusion once every three weeks).
In the expansion phase, the trial is enrolling 24 cohorts in 12 tumor types: RCC, UC, non-small cell lung cancer (NSCLC), castration-resistant prostate cancer (CRPC), hepatocellular carcinoma (HCC), triple-negative breast cancer, epithelial ovarian cancer, endometrial cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, head and neck cancer and differentiated thyroid cancer.
Three of the cohorts are exploratory single agent cohorts: one enrolled 31 patients with advanced NSCLC, one has been expanded to enroll up to 80 patients with advanced CRPC to be treated with cabozantinib as a single-agent, and one enrolled 10 patients with advanced CRPC to be treated with single-agent atezolizumab. Exploratory single agent cohorts have the option to be expanded up to 80 patients (cabozantinib) and 30 patients (atezolizumab) total.
Exelixis is the study sponsor of COSMIC-021. Both Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited (Takeda) have opted in to participate in the trial and are contributing to the funding for this study under the terms of the companies’ respective collaboration agreements with Exelixis. Roche is providing atezolizumab for the trial. More information on this trial is available on ClinicalTrials.gov.
About CAMILLA
CAMILLA is a phase 1b/2 study that is evaluating cabozantinib in combination with durvalumab with or without tremelimumab in patients with advanced gastroesophageal and gastrointestinal cancers. Upon completion of the phase 1b gastrointestinal basket trial, which included 30 patients, the trial was expanded to a phase 2, multicenter trial of 117 patients with four disease cohorts. Three cohorts are evaluating cabozantinib in combination with durvalumab in gastric and esophageal cancer, colorectal cancer and HCC. The fourth cohort is evaluating cabozantinib in combination with durvalumab and tremelimumab in HCC patients. Patients enrolled in cohort 2 (CRC) received cabozantinib 40 mg daily in combination with durvalumab 1500 mg infusion once every four weeks. CAMILLA is an investigator-sponsored trial; more information is available on ClinicalTrials.gov.
About CABOMETYX® (cabozantinib)
In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with HCC who have been previously treated with sorafenib; for patients with advanced RCC as a first-line treatment in combination with nivolumab; and for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
CABOMETYX in combination with atezolizumab or in combination with durvalumab is not indicated for colorectal cancer.
Please see accompanying full Prescribing Information https://www.cabometyx.com/downloads/CABOMETYXUSPI.pdf.
For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220118006159/en/
Source: Exelixis, Inc.
Exelixis Cabometyx combos show promise for colorectal cancer
Jan. 19, 2022 1:20 PM ET
By: Jonathan Block, SA News Editor
- A pair of abstracts that Exelixis (EXEL +0.6%) is presenting later this week at the ASCO Gastroinestinal Cancers Symposium indicate that Cabometyx (cabozantinib) in combination with immunotherapies may be effective against colorectal cancer ("CRC").
- https://seekingalpha.com/news/3789304-exelixis-cabometyx-combos-show-promise-for-colorectal-cancer
- https://seekingalpha.com/symbol/EXEL
- The first abstract is of the colorectal cancer cohort in a phase 1b multi-tumor study of cabozantinib plus Tecentriq (atezolizumab) in advanced solid tumors (COSMIC-021).
- https://www.tecentriq.com/
- The second abstract is data from a phase II trial (CAMILLA) of cabozantinib plus Imfinzi (durvalumab) in chemotherapy refractory patients with CRC.
- https://www.imfinzi.com/
- https://www.cabometyx.com/
biotecMAX™ Sept/Oct/Nov/Dec 2021 & Jan 2022 Insight
KEYTRUDA® (pembrolizumab)
Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Overall Survival (OS) Versus Placebo in Certain Patients With Advanced Hepatocellular Carcinoma (HCC) Previously Treated With Sorafenib
January 18, 2022 5:00 pm ET
First Presentation of OS Data From Phase 3 KEYNOTE-394 Trial at ASCO GI 2022
KEYNOTE-394 Is One of Seven Clinical Trials in Merck’s Global Development Program in HCC
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the final results from the Phase 3 KEYNOTE-394 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus best supportive care (BSC) in patients in Asia with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. KEYNOTE-394 is the first trial with an anti-PD-1/L1 as a second-line monotherapy treatment to show an improvement in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to placebo plus BSC for these patients. These data add to the body of evidence relating to the use of KEYTRUDA as a monotherapy in second-line HCC post sorafenib.
KEYTRUDA plus BSC demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of OS, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]; p=0.0180) compared to placebo plus BSC for patients with previously treated advanced HCC. For patients treated with KEYTRUDA plus BSC, median OS was 14.6 months (95% CI, 12.6-18.0) compared to 13.0 months (95% CI, 10.5-15.1) for patients treated with placebo plus BSC. The percentage of patients who were alive at two years was 34.3% for KEYTRUDA plus BSC compared to 24.9% for placebo plus BSC. These data will be presented at the 2022 American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium (Abstract #352788) on Friday, Jan. 21 at 10:15 a.m. ET.
“Hepatocellular carcinoma is a leading cause of cancer death across the world, and there are limited treatment options shown to extend survival for patients following treatment with sorafenib,” said Dr. Shukui Qin, director, Cancer Center of Jinling Hospital, and professor, Nanjing University of Chinese Medicine. “These overall survival data are very encouraging for patients with HCC previously treated with sorafenib and show the potential of KEYTRUDA to extend the lives of these patients.”
Treatment-related adverse events (TRAEs) occurred in 66.9% of patients in the KEYTRUDA plus BSC arm and 49.7% of patients in the placebo plus BSC arm, and Grade 3-5 TRAEs occurred in 14.4% of patients in the KEYTRUDA plus BSC arm and 5.9% of patients in placebo plus BSC arm. Immune-mediated adverse events (AEs) of any grade occurred in 18.1% of patients receiving KEYTRUDA plus BSC and 10.5% of patients receiving placebo plus BSC. Grade 3-5 immune-mediated AEs occurred in 3.0% of patients receiving KEYTRUDA plus BSC. There were three deaths (due to gastrointestinal hemorrhage, autoimmune hepatitis, and soft tissue infection) in the KEYTRUDA arm related to the study intervention.
“Patients with advanced HCC still have a high unmet medical need with low survival rates, reinforcing the need for treatment options that can improve overall survival,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We are pleased to share these new data from KEYNOTE-394 and are committed to advancing research for patients with this difficult-to-treat cancer through our broad global program in HCC.”
In the U.S., KEYTRUDA is indicated for the treatment of patients with HCC who have been previously treated with sorafenib based on ORR and duration of response (DOR) data from KEYNOTE-224. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Data from KEYNOTE-394 are being discussed with global regulatory authorities and will be evaluated as a potential confirmatory study in the U.S.
Merck is dedicated to advancing research in HCC and has a global development program of seven clinical trials that have enrolled or are expected to enroll approximately 3,000 patients. In HCC, KEYTRUDA is being studied across multiple settings and lines of therapy as monotherapy and in combination with other treatments, including therapies through our collaborations.
Study Design and Additional Data From KEYNOTE-394
KEYNOTE-394 (ClinicalTrials.gov, NCT03062358) is a randomized, double-blind Phase 3 trial evaluating KEYTRUDA plus BSC versus placebo plus BSC in Asian patients with advanced HCC previously treated with sorafenib or oxaliplatin-based chemotherapy. The primary endpoint is OS. Additional endpoints include PFS, ORR, and DOR. The study enrolled 453 patients who were randomized to receive either KEYTRUDA (intravenously every three weeks for up to 35 cycles of treatment [up to approximately two years]) plus BSC (including pain management and management of other potential complications including ascites per local standards of care) or placebo plus BSC.
Additional efficacy endpoint results of the trial showed KEYTRUDA plus BSC reduced the risk of disease progression or death by 26% (HR=0.74 [95% CI, 0.60-0.92]; p=0.0032) compared to placebo plus BSC. Median PFS was 2.6 months (95% CI, 1.5-2.8) for KEYTRUDA plus BSC and 2.3 months (95% CI, 1.4-2.8) for placebo plus BSC. KEYTRUDA plus BSC showed an ORR of 12.7% (95% CI, 9.1-17.0) and a median DOR of 23.9 months (range, 2.8 to 32.0+), where placebo plus BSC showed an ORR of 1.3% (95% CI, 0.2-4.6) and a median DOR of 5.6 months (range, 3.0+ to 5.6).
About Liver Cancer and Hepatocellular Carcinoma
Liver cancer is one of the leading causes of cancer-related deaths worldwide. It is estimated there were more than 905,000 new cases of liver cancer and more than 830,000 deaths from the disease globally in 2020. In the U.S., it is estimated there will be more than 41,000 new cases of liver cancer diagnosed and more than 30,000 deaths from this disease in 2022. An estimated 75% to 90% of primary liver cancer cases are hepatocellular carcinoma (HCC). Worldwide, major factors that increase the risk of HCC are chronic hepatitis B and chronic hepatitis C, alcohol use, and metabolic syndrome.
About KEYTRUDA® (pembrolizumab) Injection, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.
KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC, or III melanoma following complete resection.
Non-Small Cell Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:
- stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
- metastatic.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
Head and Neck Squamous Cell Cancer
KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).
KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy.
KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC):
- who are not eligible for any platinum-containing chemotherapy, or
- who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Non-muscle Invasive Bladder Cancer
KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG) -unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Microsatellite Instability-High or Mismatch Repair Deficient Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.
Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer
KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).
Gastric Cancer
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Esophageal Cancer
KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:
- in combination with platinum- and fluoropyrimidine-based chemotherapy, or
- as a single agent after one or more prior lines of systemic therapy for patients with tumors of squamous cell histology that express PD-L1 (CPS ≥10) as determined by an FDA-approved test.
Cervical Cancer
KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test.
Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Tumor Mutational Burden-High Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.
Cutaneous Squamous Cell Carcinoma
KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.
Triple-Negative Breast Cancer
KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test.
For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf .
Source: Merck & Co., Inc.
Late-stage data buoys Merck's Keytruda as second-line hepatocellular carcinoma treatment
Jan. 18, 2022 6:05 PM ET Merck & Co., Inc. (MRK)GILD By: Jonathan Block, SA News Editor4 Comments
- Phase 3 data from the KEYNOTE-394 data of Merck's (NYSE:MRK) Keytruda (pembrolizumab) showed improvement in overall survival ("OS"), progression-free survival ("PFS"), and objective response rate ("ORR") compared to placebo plus best supportive care in advanced hepatocellular carcinoma ("HCC") patients previously treated with Nexavar (sorafenib).
- https://seekingalpha.com/news/3789014-late-stage-data-buoys-mercks-keytruda-as-second-line-hepatocellular-carcinoma-treatment
- https://seekingalpha.com/symbol/MRK
- https://www.keytruda.com/
PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)
Pfizer Shares In Vitro Efficacy of Novel COVID-19 Oral Treatment Against Omicron Variant
Tuesday, January 18, 2022 - 06:45am
NEW YORK, January 18, 2022 -- Pfizer Inc. (NYSE: PFE) today shared results from multiple studies demonstrating that the in vitro efficacy of nirmatrelvir, the active main protease (Mpro) inhibitor of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), is maintained against the SARS-CoV-2 variant Omicron. Taken together, these in vitro studies suggest that PAXLOVID has the potential to maintain plasma concentrations many-fold times higher than the amount required to prevent Omicron from replicating in cells.
“We specifically designed PAXLOVID to retain its activity across coronaviruses, as well as current variants of concern with predominantly spike protein mutations. Following the clinical findings – showing PAXLOVID reduced risk of hospitalization or death by nearly 90% compared to placebo for high-risk patients when treated within five days of symptom onset – we are encouraged by these initial laboratory findings,” said Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. “These data suggest that our oral COVID-19 therapy can be an important and effective tool in our continued battle against this devastating virus and current variants of concern, including the highly transmissible Omicron. We will continue to monitor the treatment’s activity in real-world settings and believe that these in vitro findings will continue to be validated.”
In the first of these in vitro studies conducted by Pfizer, nirmatrelvir was tested against the Mpro – an enzyme that the coronavirus needs to replicate – from several SARS-CoV-2 variants of concern (VoCs), including Omicron, in a biochemical assay. The results showed in all cases that nirmatrelvir was a potent inhibitor of its target. Nirmatrelvir’s Ki – a measure of its ability to bind to an enzyme – was approximately 1 nanomolar (nM) (or Ki fold change <1) for both the Omicron and the original Washington variant (USA-WA1/2020) in this assay, indicating its continued ability to prevent in vitro viral replication. These results, together with a crystal structure demonstrating how nirmatrelvir binds to the Omicron variant, have been submitted to the online preprint server bioRxiv.
In a second in vitro study conducted by Pfizer, nirmatrelvir was tested against several SARS-CoV-2 VoCs, including Omicron, in an antiviral, cell-based assay. Reduction in viral load was measured through polymerase chain reaction (PCR) analysis, a test designed to detect the virus. Nirmatrelvir’s EC50 – a measure of drug potency showing a concentration that is effective in producing 50% of the maximal response – was 16 nM for the Omicron variant, compared to 38 nM for the USA-WA1/2020 variant, reaffirming its robust in vitro antiviral activity. These results are in line with the values that have been observed for other VoCs (Alpha, Beta, Gamma, Delta, Lambda, and Mu) in this assay, with EC50 measures ranging from 16 to 127 nM compared to USA-WA1/2020, where EC50 was 37 nM. Results from this study have been submitted to the online preprint server bioRxiv and will be submitted to a peer-reviewed journal.
An additional study, conducted by the Icahn School of Medicine at Mount Sinai (Icahn Mount Sinai) in collaboration with Pfizer, used a SARS-CoV-2-specific immunofluorescence-based assay to similarly detect the virus and measure the in vitro potency of nirmatrelvir, as well as some other authorized/approved COVID-19 therapeutics, against VoCs. In this assay, treatments were tested against the Alpha, Beta, Delta, and Omicron variants in two cell lines. IC50 values – a measure of drug efficacy indicating the concentration needed to inhibit infection by half – ranging from 22 to 225 nM for nirmatrelvir compared to USA-WA1/2020, where the IC50 was 38 to 207 nM, were observed. Results from this study have been submitted to the online preprint server bioRxiv and will be submitted to a peer-reviewed journal. These findings are consistent with data made available to the public on December 28, 2021 by the Rega Institute at KU Leuven in Belgium via the online preprint server, bioRxiv, and provide confirmation to Pfizer’s findings that nirmatrelvir is the only orally administrable, authorized/approved compound which, to date, has been shown to have low nanomolar in vitro activity against Omicron.
“Omicron is proving itself to be a formidable and highly transmissible variant of an already detrimental virus,” said Kris White, Ph.D., Assistant Professor in the Department of Microbiology at Icahn Mount Sinai). “We are heartened to see early data showing that this oral treatment is maintaining robust in vitro antiviral activity against it, as well as other variants of concern.”
Current VoCs can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. PAXLOVID, however, works intracellularly by binding to the highly conserved Mpro of the SARS-CoV-2 virus. Previous data have also indicated that PAXLOVID maintains in vitro efficacy against earlier and current VoCs, including Alpha, Beta, Gamma, Delta, Lambda, and Mu.
PAXLOVID is currently authorized for conditional or emergency use in several countries across the globe. Pfizer has submitted applications for regulatory approval or authorization to multiple regulatory agencies and anticipates further regulatory decisions to follow.
Please see Full Emergency Use Authorization (EUA) Prescribing Information available at www.fda.gov and www.COVID19oralRx.com.
About PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)
PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It was developed to be administered orally so that it can be prescribed at the first sign of infection or, pending clinical success of the rest of the EPIC development program and subject to regulatory authorization, at first awareness of an exposure – potentially helping patients avoid severe illness (which can lead to hospitalization and death) or avoid disease development following contact with a household member who contracts COVID-19. Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.
Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.
PAXLOVID is authorized to be administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.
Under the Emergency Use Authorization, the U.S. Government and State Governments decide how PAXLOVID is distributed among pharmacies, hospitals, urgent cares, and other entities. Healthcare providers and healthcare facilities should contact their state health department to determine how to access product. Additional information about how the U.S. Department of Health and Human Services will supply PAXLOVID can be found at www.PHE.gov and https://www.hhs.gov/coronavirus/covid-19-treatments-therapeutics/index.html. Locations of publicly available COVID-19 Therapeutics can be found at COVID-19 Public Therapeutic Locator | HealthData.gov.
Emergency Use Authorization Statement
PAXLOVID has not been approved, but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death.
The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
AUTHORIZED USE
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
LIMITATIONS OF AUTHORIZED USE
• PAXLOVID is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19
• PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19
• PAXLOVID is not authorized for use for longer than 5 consecutive days
PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which PAXLOVID belongs (i.e., anti-infectives).
PAXLOVID is not approved for any use, including for use for the treatment of COVID-19.
PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.
https://www.pfizer.com/products/product-detail/paxlovidtm
PAXLOVID™ (nirmatrelvir and ritonavir)
This product information is intended only for residents of the United States.
for Consumers:
for Healthcare professionals:
Pfizer says lab studies indicate COVID antiviral Paxlovid effective against Omicron
Jan. 18, 2022 1:35 PM ET Pfizer Inc. (PFE)
By: Jonathan Block, SA News Editor6 Comments
- Pfizer (PFE -2.3%) says that several lab studies it has conducted indicate that its COVID-19 antiviral pill Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir) is effective against the Omicron variant.
- https://seekingalpha.com/news/3788862-pfizer-says-lab-studies-indicate-covid-antiviral-paxlovid-effective-against-omicron
- https://seekingalpha.com/symbol/PFE
- https://www.pfizer.com/products/product-detail/paxlovidtm
JYSELECA®▼ (FILGOTINIB)
JYSELECA®▼ (FILGOTINIB) LICENSED FOR THE TREATMENT OF ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS IN GREAT BRITAIN
Mechelen, Belgium; 18 January 2022; 22.01 CET; Galapagos NV (Euronext & Nasdaq: GLPG) announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for Jyseleca® (filgotinib 200mg tablets), as a new treatment for ulcerative colitis (UC) for Great Britain.
The MHRA has licensed an additional indication for Jyseleca, an oral once-daily, JAK1 preferential inhibitor, for use in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. The submission was supported by data from the Phase 2b/3 SELECTION program, published in the Lancet1. The decision from the MHRA follows authorisation from the European Commission (EC) for use in the same patient population.
Michele Manto, Chief Commercial Officer at Galapagos said: “At Galapagos we are committed to bringing new and innovative medicines to healthcare professionals who are treating patients with UC and today we are one step closer to offering a new treatment option to thousands of patients living in Great Britain with UC, a chronic and debilitating disease. Together with the EC decision, this decision represents an important milestone in our plans to make Jyseleca available to eligible adult patients with UC across Europe.”
Dr Ian Beales, Consultant in Gastroenterology and General Medicine, Norfolk and Norwich University Hospital and Chief Investigator for the SELECTION study in the UK said: “The prevalence of UC in the UK is increasing. 1 in every 420 people are currently estimated to have the disease. Despite available treatments there is still a need for innovative new therapies to provide relief from the symptoms that can have debilitating physical consequences for patients. In the SELECTION study when compared to placebo, more patients on filgotinib 200mg demonstrated corticosteroid-free remission from clinical symptoms with improvements in measures of health-related quality of life and was well-tolerated by patients. We welcome having a new treatment option available to help us with managing this disease.”
UC is a life-long condition characterized by inflammation of the mucosal lining of the colon and rectum. Current estimates suggest that in the UK more than 146,0002 people are currently living with UC. The prevalence of inflammatory bowel diseases, which includes UC, is rising in the UK with peak diagnosis in late adolescence or early adulthood3.
Ruth Wakeman, Director of Services, Advocacy & Evidence, Crohn’s & Colitis UK, said: “Ulcerative Colitis can be an extremely debilitating condition, affecting many parts of the body and many aspects of life. It can affect people in very individual ways, so effective and appropriate treatment based on personalized care and shared decision making is really important. For some people with UC, existing treatments may not work, so additional treatment options are welcome.”
About filgotinib
Filgotinib is licensed and marketed as Jyseleca (200mg and 100mg tablets) in Great Britain, the European Union and Japan for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be used as monotherapy or in combination with methotrexate (MTX). Filgotinib is also licensed and marketed as Jyseleca in Great Britain and the European Union for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. An application has been submitted to the Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with moderately to severely active UC and is currently under review. The Great Britain Summary of Product Characteristics for filgotinib can be found at www.medicines.org.uk/emc and the Northern Ireland Summary of Product Characteristics for filgotinib can be found at www.emcmedicines.com/en-GB/northernireland. The European Summary of Product Characteristics for filgotinib, which includes contraindications and special warnings and precautions, is available at www.ema.europa.eu. The interview form from the Japanese Ministry of Health, Labour and Welfare is available at www.info.pmda.go.jp. A global Phase 3 program with filgotinib is ongoing in Crohn’s Disease. More information about clinical trials can be accessed at https://www.clinicaltrials.gov.
Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.
About the filgotinib collaboration
Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib. Galapagos is responsible for the commercialization of filgotinib in Europe, while Gilead remains responsible for filgotinib outside of Europe, including in Japan, where filgotinib is co-marketed with Eisai.
Galapagos' Jyseleca wins UK marketing authorization for ulcerative colitis
Jan. 18, 2022 4:29 PM ET
By: Jonathan Block, SA News Editor
- The UK's Medicines and Healthcare products Regulatory Agency has approved Galapagos' (NASDAQ:GLPG) oral JAK1 inhibitor Jyseleca (filgotinib) for ulcerative colitis ("UC").
- https://seekingalpha.com/symbol/GLPG
- https://www.ema.europa.eu/en/medicines/human/EPAR/jyseleca
PREVNAR 20™ With Pfizer-BioNTech COVID-19 Vaccine
Positive Top-Line Results of Pfizer’s Phase 3 Study Exploring Coadministration of PREVNAR 20™ With Pfizer-BioNTech COVID-19 Vaccine in Older Adults Released
Wednesday, January 12, 2022 - 06:45am
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) today announced positive top-line results from a Phase 3 study (B74710126) describing the safety and immunogenicity of PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) in 570 adults in the United States 65 years of age or older when administered at the same time as the Pfizer-BioNTech COVID-19 Vaccine or when each vaccine was given with placebo.
Responses elicited by PREVNAR 20 for all 20 serotypes were similar whether given with a dose of the Pfizer-BioNTech COVID-19 Vaccine (n=190) or with placebo (n=191). Responses to a booster dose of the Pfizer-BioNTech COVID-19 Vaccine were also similar when given with PREVNAR 20 or given with placebo (n=189). The safety profile of co-administering PREVNAR 20 with a booster dose of the Pfizer-BioNTech COVID-19 Vaccine generally reflected that observed with the Pfizer-BioNTech COVID-19 Vaccine booster dose.
“Pfizer is steadfast in its commitment to address the burden of certain respiratory diseases while raising awareness of the importance of adult immunizations,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “These new safety and immunogenicity data provide further evidence supporting the potential to administer PREVNAR 20 and the Pfizer-BioNTech COVID-19 Vaccine at the same time, thereby reducing the number of visits adults make to their doctor’s office or pharmacy for recommended immunization. As the COVID-19 vaccines and booster doses continue to be administered, we believe that healthcare providers have an opportunity to talk to their adult patients about other recommended vaccines in line with CDC guidance.”
The initiation of the study exploring the coadministration of PREVNAR 20 along with a booster dose of the Pfizer-BioNTech COVID-19 Vaccine in older adults was announced in May 2021. The study recruited adults from the pivotal Phase 3 Pfizer-BioNTech COVID-19 Vaccine clinical trial and included adults who received their second dose of the vaccine at least six months prior to entering the coadministration study. Pfizer will seek to present and publish detailed outcomes from this clinical trial at a future date. At this time no coadministration data are included in the PREVNAR 20 or Pfizer-BioNTech COVID-19 Vaccine prescribing information.
About PREVNAR 20
PREVNAR 20 is Pfizer’s next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD),1,2,3,4,5 and have been associated with high case-fatality rates,6,7,8,9 antibiotic resistance,10,11,12 and/or meningitis.13,14 PREVNAR 20 contains the broadest conjugate serotype coverage and helps protect against more strains of the bacteria that cause pneumococcal pneumonia than any other conjugate vaccine available.
On June 8, 2021, Pfizer announced the U.S. Food and Drug Administration (FDA) approved PREVNAR 20, which is the U.S. trade name, for the prevention of invasive disease and pneumonia in adults age 18 years or older. On December 16, 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the granting of a marketing authorization for the 20-valent pneumococcal conjugate vaccine candidate for the prevention of invasive disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes in adults ages 18 years and older in the 27 European Union (EU) member states plus Iceland, Lichtenstein and Norway. The EMA had previously accepted review of Pfizer’s Marketing Authorization Application (MAA) for the 20-valent pneumococcal conjugate vaccine candidate on February 26, 2021.
Pfizer has recently submitted to the FDA a supplemental Biologics License Application to include data in the PREVNAR 20 prescribing information for adults age 18 years or older regarding coadministration of PREVNAR 20 with a seasonal inactivated influenza vaccine.
Pivotal Phase 3 studies of the 20-valent pneumococcal conjugate vaccine candidate in infants are expected to read out in the second half of 2022 and, if positive, form the basis of potential regulatory submissions to the FDA and EMA later this year.
U.S. INDICATIONS FOR PREVNAR 20™
- PREVNAR 20™ is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older
- This indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Please see full prescribing information for PREVNAR 20™.
COMIRNATY® U.S. Indication & Authorized Use
HOW IS THE VACCINE GIVEN?
The vaccine will be given to you as an injection into the muscle.
Primary Series:
In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart.
In individuals 5 years of age and older, a third primary series dose may be administered at least 28 days after the second dose to individuals who are determined to have certain kinds of immunocompromise.
Booster Dose:
- A single booster dose of the vaccine may be administered at least 5 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older
- A single booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. Individuals should check with their healthcare provider regarding timing of the booster dose
WHAT IS THE INDICATION AND AUTHORIZED USE?
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:
- a 2-dose primary series to individuals 5 years of age and older
- a third primary series dose to individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise
- a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
- a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
- It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
- It is also authorized under EUA to provide:
- a 2-dose primary series to individuals 12 through 15 years of age
- a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
- a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
- a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
Click for
Fact Sheets and Prescribing Information for individuals 12 years of age and older
Full Prescribing Information (16 years of age and older) DILUTE BEFORE USE, Purple Cap
Full Prescribing Information (16 years of age and older) DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray Cap
Recipients and Caregivers Fact Sheet (12 years of age and older)
Fact Sheets for individuals 5 through 11 years of age
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange Cap
Recipients and Caregivers Fact Sheet (5 through 11 years of age)
In addition, to learn more, please visit us on www.Pfizer.com
Pfizer reports positive results from Phase 3 study of PREVNAR 20 with COVID-19 vaccine
Jan. 12, 2022 7:01 AM ET Pfizer Inc. (PFE)By: Mamta Mayani, SA News Editor2 Comments
- Pfizer (NYSE:PFE) announces positive top-line results from a Phase 3 study describing the safety and immunogenicity of PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) in 570 adults in U.S. aged 65 years or older when administered at the same time as the Pfizer-BioNTech COVID-19 Vaccine or when each vaccine was given with placebo.
- https://seekingalpha.com/news/3787390-pfizer-reports-positive-results-from-phase-3-study-of-prevnar-20-with-covid-19-vaccine
- https://seekingalpha.com/symbol/PFE
- https://prevnar20.pfizerpro.com/
CIBINQO® (abrocitinib)
In addition, to learn more, please visit us on www.pfizer.com
U.S. FDA Approves Pfizer’s CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis
Friday, January 14, 2022 - 03:30pm
CIBINQO is a once-daily oral treatment with proven efficacy to manage symptoms for adults who have not yet found relief with current options
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved CIBINQO® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
CIBINQO is approved at the recommended doses of 100 mg and 200 mg, with the 200 mg dose being recommended for patients who are not responding to the 100 mg dose. Additionally, a 50 mg dose was approved to treat moderate-to-severe AD specifically in patients with moderate renal impairment (kidney failure), certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19, or patients who are known or suspected to be poor metabolizers of CYP2C19. For patients with moderate renal impairment who are not responding to 50 mg once daily, 100 mg once daily may also be prescribed.
“The reality for patients living with chronic inflammatory skin disease such as moderate-to-severe atopic dermatitis is that many experience debilitating symptoms that are not managed by current treatment options. Today’s approval of CIBINQO will provide an important new oral option that could help those who have yet to find relief,” said Jonathan Silverberg, MD, PhD, MPH, Department of Dermatology, The George Washington University School of Medicine and Health Sciences. “In multiple large-scale clinical trials, CIBINQO demonstrated strong efficacy at clearing skin, improving itch, and managing the extent and severity of eczema, offering a benefit-risk profile that supports the use of this treatment in the FDA-approved patient population.”
The FDA approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. The safety and efficacy of CIBINQO was evaluated in three randomized, placebo-controlled, Phase 3 trials. Additionally, safety was evaluated through a randomized, placebo-controlled, dose-ranging trial and an ongoing long-term open-label extension trial. Across the trials, CIBINQO demonstrated a consistent safety profile and profound improvements in skin clearance, extent of disease, and severity, as well as rapid improvement in itch after two weeks, for some people living with AD versus placebo. In addition, a higher proportion of subjects treated with CIBINQO in two monotherapy trials achieved improvement in itching at week 12 compared to placebo.
“The FDA’s approval offers hope to the millions of patients across the U.S. who are suffering daily with an immuno-inflammatory condition that can cause intense and persistent itching, pain, discomfort, and distress if left uncontrolled,” said Mike Gladstone, Global President of Pfizer Inflammation & Immunology. “CIBINQO, an efficacious once-daily pill, is a medical breakthrough made possible by Pfizer researchers and the people living with moderate-to-severe atopic dermatitis who participated in our clinical trials.”
“Atopic dermatitis is so much more than just a rash, and it goes beyond the surface of the skin. It’s a chronic condition that can both significantly disrupt patients’ daily lives and negatively impact their emotional well-being,” said Julie Block, President and CEO, National Eczema Association. “We appreciate Pfizer’s commitment to this resilient patient community and eagerly await the positive impact CIBINQO could have on the treatment landscape for moderate-to-severe atopic dermatitis.”
The most common adverse events reported in ≥5% of patients with CIBINQO included nasopharyngitis (12.4% with CIBINQO 100 mg, 8.7% with CIBINQO 200 mg, and 7.9%, with placebo), nausea (6%, 14.5%, and 2.1%, respectively), and headache (6%, 7.8%, and 3.5%, respectively).
The full prescribing information for CIBINQO can be found here. CIBINQO will be made available in the coming weeks.
Indication
CIBINQO is indicated for the treatment of adults with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.
Limitations of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
About CIBINQO® (abrocitinib)
CIBINQO is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).
In addition to receiving regulatory approval in the U.S., CIBINQO has received marketing authorization in the European Union, Great Britain, Japan, Korea, the United Arab Emirates, Norway, Iceland, and Singapore.
Source: Pfizer Inc.
Pfizer granted FDA approval for CIBINQO in atopic dermatitis
Jan. 14, 2022 4:14 PM ET Pfizer Inc. (PFE)ABBV
By: Dulan Lokuwithana, SA News Editor4 Comments
- Pfizer (NYSE:PFE) announced the FDA approval of its Janus kinase 1 (JAK1) inhibitor CIBINQO (abrocitinib) as a treatment for adults with refractory, moderate-to-severe atopic dermatitis (AD).
- https://seekingalpha.com/news/3788420-pfizer-granted-fda-approval-for-cibinqo-in-atopic-dermatitis
- https://seekingalpha.com/symbol/PFE
RINVOQ® (upadacitinib)
January 14, 2022
U.S. FDA Approves RINVOQ® (upadacitinib) to Treat Adults and Children 12 Years and Older with Refractory, Moderate to Severe Atopic Dermatitis
- Approval of two dose strengths (15 mg and 30 mg) supported by efficacy and safety data from one of the largest registrational Phase 3 programs in atopic dermatitis, with more than 2,500 patients evaluated across three studies[1]
- RINVOQ (upadacitinib) monotherapy or with topical corticosteroids met all primary and ranked secondary endpoints in atopic dermatitis pivotal studies[1-3]
- RINVOQ demonstrated significant improvement in itch (Worst Pruritus NRS ≥4) as early as week one, as well as significant improvements in skin clearance (EASI 75 and vIGA-AD 0/1) at 16 weeks, compared to placebo[1-3]
- RINVOQ also demonstrated significantly higher levels of skin clearance (EASI 90 and 100) at 16 weeks, compared to placebo[1-3]
NORTH CHICAGO, Ill., Jan. 14, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended.1 RINVOQ 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg.1 In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily.1
"Early in my career as an allergist, I saw how relentless the itch and rash could be for my patients with moderate to severe atopic dermatitis yet had limited options to offer those whose disease could not be adequately controlled with systemic therapy," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "This additional approval for RINVOQ provides a once-daily oral option that can significantly improve the debilitating itch and skin symptoms of atopic dermatitis. It's also a proud moment for AbbVie as we continue our efforts to improve care in this disease state and other chronic, immune-mediated conditions."
The FDA approval is supported by efficacy and safety data from one of the largest registrational Phase 3 programs for atopic dermatitis with more than 2,500 patients evaluated across three studies. Approximately 52 percent of the patients had prior exposure to systemic atopic dermatitis treatment. These studies evaluated the efficacy and safety of RINVOQ monotherapy (Measure Up 1 and 2) and with topical corticosteroids (AD Up), compared to placebo, in adults and children 12 years of age and older with moderate to severe atopic dermatitis.2-3
"Despite available therapies, many people with moderate to severe atopic dermatitis are caught in an endless cycle of itching and scratching," said Emma Guttman-Yassky, M.D., Ph.D., Waldman Professor and System Chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City.* "In clinical trials, upadacitinib showed a robust response across skin and itch symptoms that may help evolve treatment goals for those who have not achieved adequate control of their disease. And as an oral pill with two dose strengths, upadacitinib is a welcome addition to the toolbox of clinicians who are striving to make a significant difference for their patients with moderate to severe atopic dermatitis."
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.10 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.1 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.
In the U.S., RINVOQ 15 mg and 30 mg is approved for use in adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.1 RINVOQ 15 mg is also approved in the U.S. for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers as well as adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. In the EU, RINVOQ 15 mg is approved for the treatment of adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis and adults with active ankylosing spondylitis. RINVOQ is also approved in the EU for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis.
Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing. 11-18
RINVOQ® (upadacitinib) U.S. Use and Important Safety Information1
RINVOQ is a prescription medicine used to treat:
- Adults with moderate to severe rheumatoid arthritis when 1 or more tumor necrosis factor (TNF) blockers have been used and did not work well or could not be tolerated.
- Adults with active psoriatic arthritis when 1 or more tumor necrosis factor (TNF) blockers have been used and did not work well or could not be tolerated.
It is not known if RINVOQ is safe and effective in children under 18 years of age with juvenile idiopathic arthritis or psoriatic arthritis.
- Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis) who did not respond to previous treatment and whose eczema is not well controlled with other pills or injections, including biologic medicines, or when the use of other pills or injections is not recommended.
RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.
It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.
SOURCE AbbVie
AbbVie gains on FDA approval for RINVOQ in atopic dermatitis
Jan. 14, 2022 2:40 PM ET AbbVie Inc. (ABBV)
By: Dulan Lokuwithana, SA News Editor6 Comments
AbbVie (ABBV +1.3%) pared early losses to rise in afternoon hours on the announcement of FDA approval for the company’s JAK inhibitor RINVOQ (upadacitinib) for moderate to severe atopic dermatitis (AD).
- https://seekingalpha.com/news/3788396-abbvie-gains-on-fda-approval-for-rinvoq-in-atopic-dermatitis
- https://seekingalpha.com/symbol/ABBV