VENCLEXTA®/ VENCLYXTO® (venetoclax)

Venclexta-based Treatments in Chronic Lymphocytic Leukemia Sun December 8, 2019 7:30 AM RHHBY

New Long-Term Data Continues to Demonstrate Progression-Free Survival and Overall Survival Benefits with VENCLEXTA®/ VENCLYXTO® (venetoclax) Combination in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

- Four-year updated analysis from the MURANO trial showed an 81% reduction in the risk of disease progression or death in patients treated with VENCLEXTA®/VENCLYXTO® (venetoclax) plus rituximab (VenR) and higher rates of minimal residual disease (MRD)-negativity compared to bendamustine plus rituximab (BR)[1]

- The risk of death was decreased by 59% in the 130 patients who completed VenR, versus BR, despite 79% of patients in the BR arm who went on to receive a novel targeted treatment. Median overall survival (OS) was not reached for either treatment group[1]

- Sixty-eight percent of the 130 patients who completed the treatment course were free of disease progression and maintained OS benefit 24-months after being off therapy[1]

- Full results are being highlighted today in an oral presentation at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition

NEWS PROVIDED BY

AbbVie

Dec 08, 2019, 07:30 ET

NORTH CHICAGO, Ill., Dec. 8, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV)

https://www.prnewswire.com/news-releases/new-long-term-data-continues-to-demonstrate-progression-free-survival-and-overall-survival-benefits-with-venclexta-venclyxto-venetoclax-combination-in-patients-with-relapsedrefractory-chronic-lymphocytic-leukemia-cll-300971015.html

https://www.abbvie.com/our-science/therapeutic-focus-areas/oncology.html

GAZYVA® (obinutuzumab) is a prescription medicine used in combination with chemotherapy, followed by GAZYVA alone in those who responded, to treat stage II bulky, III or IV follicular lymphoma (FL) in adults who have not had previous FL treatment.

GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, bendamustine, followed by GAZYVA alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.

GAZYVA® (obinutuzumab) is a prescription medicine used with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.

https://www.gazyva.com/

New Long-Term Data Continues to Demonstrate Progression-Free Survival and Overall Survival Benefits with VENCLEXTA®/ VENCLYXTO® (venetoclax) Combination in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Sun December 8, 2019 7:30 AM|PR Newswire|About: ABBV

Venclexta-based Treatments in Chronic Lymphocytic Leukemia

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.

VENCLEXTA was approved based on response rates. Continued approval for this use may depend on the results of an ongoing study to find out how VENCLEXTA works over a longer period of time.

https://www.venclexta.com/

Rituxan is a prescription medicine used to treat adults with:

Non-Hodgkin’s Lymphoma (NHL): alone or with other chemotherapy medicines.
Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide.
Rheumatoid arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well enough.
Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids.
Pemphigus Vulgaris (PV): to treat moderate to severe PV.

https://www.rituxan.com/

New Data Demonstrate the Continued Clinical Benefit of Fixed-duration, Chemotherapy-free Venclexta-based Treatments in Chronic Lymphocytic Leukemia Sun December 8, 2019 7:30 AM|Business Wire|About: RHHBY – In an updated analysis of the CLL14 study, Venclexta plus Gazyva achieved remissions that were sustained over time in people with previously untreated chronic lymphocytic leukemia – – At four-year follow-up of the MURANO study, Venclexta plus Rituxan continued to reduce disease progression compared to a standard-of-care therapy in previously treated chronic lymphocytic leukemia – – Data presented on both studies includes results on minimal residual disease, which is currently emerging as a potential surrogate endpoint – SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

VENCLYXTO® (venetoclax) in combination with obinutuzumab

AbbVie Receives European Commission Approval of VENCLYXTO® Combination Regimen for Patients with Previously-Untreated Chronic Lymphocytic Leukemia

- VENCLYXTO® plus obinutuzumab is the first chemotherapy-free, fixed-duration combination regimen approved by the European Commission (EC) for patients with previously untreated chronic lymphocytic leukemia (CLL)

- Approval is based on data from the Phase 3 CLL14 trial, which showed that patients treated with obinutuzumab plus one year of treatment with VENCLYXTO had superior progression-free survival (PFS) and higher rates of undetectable minimal residual disease compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil[1],[5]

https://www.prnewswire.com/news-releases/abbvie-receives-european-commission-approval-of-venclyxto-combination-regimen-for-patients-with-previously-untreated-chronic-lymphocytic-leukemia-301021997.html

March 12, 2020 AbbVie Receives European Commission Approval of VENCLYXTO® Combination Regimen for Patients with Previously-Untreated Chronic Lymphocytic Leukemia

Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYX

Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®)

November 21, 2019

AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting

- AbbVie will present more than 40 abstracts featuring data from approved and investigational medicines
- New minimal residual disease (MRD) data from CAPTIVATE clinical trial evaluating ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) in first-line treatment chronic lymphocytic leukemia (CLL) will be featured during the CLL Therapy Oral Session (abstract #35)
- Latest data from the ECOG-ACRIN Cancer Research Group-led Phase 3 E1912 study of ibrutinib in combination with rituximab, which served as the basis of a recent FDA sNDA submission, will be presented during the CLL Therapy Oral Session (Abstract #33)
- New long-term data from the MURANO trial evaluating continued benefit with fixed duration venetoclax plus rituximab in patients with relapsed/refractory (R/R) CLL will also be featured in the CLL Therapy Oral Session (abstract #355)

NORTH CHICAGO, Ill., Nov. 21, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that more than 40 abstracts, including 18 oral presentations, will be presented during the upcoming American Society of Hematology (ASH) Annual Meeting & Exposition, December 7-10, in Orlando, FL. New data include presentations on Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) among others.

November 21, 2019 AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting

ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) chronic lymphocytic leukemia (CLL)

AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting

- AbbVie will present more than 40 abstracts featuring data from approved and investigational medicines

- New minimal residual disease (MRD) data from CAPTIVATE clinical trial evaluating ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) in first-line treatment chronic lymphocytic leukemia (CLL) will be featured during the CLL Therapy Oral Session (abstract #35)

- Latest data from the ECOG-ACRIN Cancer Research Group-led Phase 3 E1912 study of ibrutinib in combination with rituximab, which served as the basis of a recent FDA sNDA submission, will be presented during the CLL Therapy Oral Session (Abstract #33)

- New long-term data from the MURANO trial evaluating continued benefit with fixed duration venetoclax plus rituximab in patients with relapsed/refractory (R/R) CLL will also be featured in the CLL Therapy Oral Session (abstract #355)

https://www.prnewswire.com/news-releases/abbvie-to-present-latest-clinical-research-in-the-treatment-of-leukemias-lymphomas-and-other-blood-cancers-at-2019-ash-annual-meeting-300962704.html

AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting Thu November 21, 2019 8:30 AM|PR Newswire|About: ABBV

Ibrutinib (IMBRUVICA®)

Ibrutinib (IMBRUVICA®)

IMBRUVICA (ibrutinib) is an oral, once-daily medicine that works differently than chemotherapy as it blocks a protein called Bruton's tyrosine kinase (BTK). The BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiple and spread.1,2 By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.3

What is IMBRUVICA® (ibrutinib)? IMBRUVICA® (ibrutinib) is a prescription medicine used to treat adults with: Mantle cell lymphoma (MCL) who have received at least one prior treatment Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion Waldenström's macroglobulinemia (WM) Marginal zone lymphoma (MZL) who require a medicine by mouth or injection (systemic therapy) and have received a certain type of prior treatment Chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy

VENCLEXTA®/VENCLYXTO® (venetoclax)

VENCLEXTA®/VENCLYXTO® (venetoclax)

VENCLEXTA®/VENCLYXTO® (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLEXTA/VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLEXTA is indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who: are 75 years of age or older, or have comorbidities that preclude the use of intensive induction chemotherapy. This indication is approved under accelerated approval based on response rates. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Data Show High Rates of Disease Clearance in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL)

- New results from the Phase 2 CAPTIVATE clinical trial show the potential of this fixed-duration, combination therapy for CLL patients starting treatment for the first time

- Data will be presented at an oral presentation session at the 2019 American Society of Hematology (ASH) Annual Meeting (abstract #35)

NEWS PROVIDED BY

AbbVie

Dec 07, 2019, 07:30 ET

https://www.prnewswire.com/news-releases/imbruvica-ibrutinib-plus-venclextavenclyxto-venetoclax-combination-data-show-high-rates-of-disease-clearance-in-previously-untreated-patients-with-chronic-lymphocytic-leukemia-cll-300970907.html

https://imbruvica.com/

https://www.venclexta.com/?c=ABV_ppc_ppd_cll_br_ggl_5612&cpcd=gdc-1684e83d0eb

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Data Show High Rates of Disease Clearance in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL) Sat December 7, 2019 7:30 AM|PR Newswire|About: ABBV - Data will be presented at an oral presentation session at the 2019 American Society of Hematology (ASH) Annual Meeting (abstract #35) PR Newswire NORTH CHICAGO, Ill., Dec. 7, 2019 /PRNewswire/ -- AbbVie (ABBV)

KEYTRUDA® (pembrolizumab) KEYTRUDA® +LENVIMA® (lenvatinib

KEYTRUDA® (pembrolizumab)= Metastatic or Unresectable Recurrent Head & Neck Squamous Cell Carcinoma

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer With Carcinoma In Situ With or Without Papillary Tumors Who Are Ineligible for or Have Elected Not to Undergo Cystectomy

KEYTRUDA Is the First Anti-PD-1 Therapy Approved for Certain Patients With High-Risk, Non-Muscle Invasive Bladder Cancer

Wednesday, January 8, 2020 4:31 pm EST

https://www.mrknewsroom.com/news-release/oncology/fda-approves-mercks-keytruda-pembrolizumab-patients-bcg-unresponsive-high-risk

https://www.merckaccessprogram-keytruda.com/hcc/

Merck Receives Positive EU CHMP Opinion for Two New Regimens of KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma

Opinion Supports Use of KEYTRUDA, as Monotherapy or in Combination with Platinum and 5-Fluorouracil Chemotherapy, in Patients Whose Tumors Express PD-L (CPS ≥1)

October 18, 2019 07:00 AM Eastern Daylight Time

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada
https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf
https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
https://www.merck.com/clinical-trials/index.htm

FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Tue December 17, 2019 5:15 PM|Business Wire|About: MRK

https://seekingalpha.com/pr/17731041-fda-oncologic-drugs-advisory-committee-odac-recommends-keytruda-pembrolizumab-for-treatment

https://clinicaltrials.gov/ct2/show/NCT02625961

https://www.keytruda.com/

FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Tuesday, December 17, 2019 5:15 pm EST
https://www.mrknewsroom.com/news-release/oncology/fda-oncologic-drugs-advisory-committee-odac-recommends-keytruda-pembrolizumab-

European Commission Approves Two New Regimens of Merck’s KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

KEYTRUDA is the First Anti-PD-1 Therapy Approved in Europe for the First-Line Treatment of Head and Neck Cancer as Monotherapy or in Combination with Chemotherapy, in Patients Whose Tumors Express PD-L1 (CPS ≥1)Approval Based on Significant Overall Survival Findings from Phase 3 KEYNOTE-048 TrialNovember 20, 2019 06:45 AM Eastern Standard TimeKENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada

https://www.businesswire.com/news/home/20191120005267/en/

https://www.merck.com/research/index.html#IntroVideo

https://www.merck.com/clinical-trials/index.html

https://www.keytruda.com/

https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.p

European Commission Approves Two New Regimens of Merck’s KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

Wed November 20, 2019 6:45 AM|Business Wire|About: MRK

https://seekingalpha.com/pr/17705201-european-commission-approves-two-new-regimens-merck-s-keytruda-pembrolizumab-first-line

Merck Receives Positive EU CHMP Opinion for Two New Regimens of KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma Opinion Supports Use of KEYTRUDA, as Monotherapy or in Combination with Platinum and 5-Fluorouracil Chemotherapy, in Patients Whose Tumors Express PD-L (CPS ≥1) Friday, October 18, 2019 7:00 am EDT

Merck’s KEYTRUDA® (pembrolizumab) Now Approved as Monotherapy in China for First-Line Treatment of Certain Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express PD-L1

https://seekingalpha.com/pr/17650568-merck-s-keytruda-pembrolizumab-now-approved-monotherapy-china-first-line-treatment-certain

https://www.businesswire.com/news/home/20191002005162/en/

https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf

https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf

Merck’s KEYTRUDA® (pembrolizumab) Now Approved as Monotherapy in China for First-Line Treatment of Certain Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express PD-L1 KEYTRUDA is First Anti-PD-1 Therapy Approved as Monotherapy and in Combination with Chemotherapy in First-Line Setting for NSCLC in China Wednesday, October 2, 2019 6:45 am EDT

KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib)

FDA Approves KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma

http://www.lenvima.com/hcp/

FDA Approves LENVIMA® (lenvatinib) plus KEYTRUDA® (pembrolizumab) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma

https://www.eisai.com/news/2019/news201967.html

https://site-search.eisai.co.jp/eng/?ref=https%3A%2F%2Fwww.eisai.com%2Findex.html&kw=LENVIMA&ie=u&temp=en&sort=s&cond[]=all&pdf=on&by=js

https://www.eisai.com/index.html

FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Mon December 2, 2019 6:45 AM|Business Wire|About: MRK

https://seekingalpha.com/pr/17714311-fda-grants-priority-review-merck-s-supplemental-biologics-license-application-sbla-keytruda

https://www.businesswire.com/news/home/20191202005300/en/

https://clinicaltrials.gov/ct2/show/NCT02625961

FDA Approves KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma Combination Treatment Approved for Patients with Advanced Endometrial Carcinoma That Is Not Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR), Who Have Disease Progression Following Prior Systemic Therapy and Are Not Candidates for Curative Surgery or Radiation Under New FDA-Initiated Program, Combination Treatment Is the First to Receive Simultaneous Review Decisions in the U.S., Australia and Canada Tuesday, September 17, 2019 5:56 pm EDT

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Showed Statistically Significant Increase in Pathological Complete Response Versus Chemotherapy as Neoadjuvant Therapy in Early-Stage Triple-Negative Breast Cancer (TNBC)

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Showed Statistically Significant Increase in Pathological Complete Response Versus Chemotherapy as Neoadjuvant Therapy in Early-Stage Triple-Negative Breast Cancer (TNBC) Interim Results from Pivotal Neoadjuvant/Adjuvant Phase 3 KEYNOTE-522 Trial Presented for the First Time at ESMO 2019 Congress During Presidential Symposium As Previously Announced, KEYTRUDA Plus Chemotherapy Has Been Granted Breakthrough Therapy Designation by US FDA for Neoadjuvant Treatment of High-Risk, Early-Stage TNBC Sunday, September 29, 2019 10:30 am EDT

Keytruda Set to Become World’s Top-Selling Drug,

Keytruda Approvals: A Timeline

Published: Aug 13, 2019 By Alex Keown

https://www.biospace.com/article/keytruda-approvals-a-timeline/

Keytruda Set to Become World’s Top-Selling Drug, Forecast Shows Published: Oct 04, 2019 By Alex Keown

Marks First Approval for KEYTRUDA in SCLC

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Monotherapy for Patients with Metastatic Small Cell Lung Cancer (SCLC) with Disease Progression on or After Platinum-Based Chemotherapy and at Least One Other Prior Line of Therapy

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Monotherapy for Patients with Metastatic Small Cell Lung Cancer (SCLC) with Disease Progression on or After Platinum-Based Chemotherapy and at Least One Other Prior Line of Therapy Marks First Approval for KEYTRUDA in SCLC June 18, 2019 06:45 AM Eastern Daylight Time KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK

IMBRUVICA® (ibrutinib)

Phase 3 Study of Ibrutinib (IMBRUVICA®) in Metastatic Pancreatic Cancer

AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Metastatic Pancreatic Cancer

https://www.prnewswire.com/news-releases/abbvie-provides-update-on-phase-3-study-of-ibrutinib-imbruvica-in-metastatic-pancreatic-cancer-300781119.html

https://imbruvica.com/

https://www.abbvie.com/our-science/pipeline/imbruvica.html

https://www.abbvie.com/search.html?search=IMBRUVICA%C2%AE+%28ibrutinib%29&_charset_=UTF-8

AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Metastatic Pancreatic Cancer Fri January 18, 2019 4:29 PM|PR Newswire|About: ABBV -- The study did not show statistically-significant progression-free or overall survival benefit with ibrutinib in combination versus the placebo combination study arm -- Metastatic pancreatic cancer is one of the most aggressive and deadliest forms of cancer, with an estimated 5-year survival of less than 5 percent1 -- IMBRUVICA is currently approved by the U.S. FDA in six disease areas with nine treatment indications and has cumulatively treated more than 135,000 patients globally in clinical practice and trials PR Newswire NORTH CHICAGO, Ill., Jan. 18, 2019 /PRNewswire/ -- AbbVie (ABBV)

Phase 3 study of ibrutinib (IMBRUVICA®) in untreated (treatment-naïve) diffuse large B-cell lympho

The ibrutinib clinical program is designed to fully explore the potential of this first-in-class molecule as a single or combination therapy for multiple cancers and other diseases. Fourteen Phase 3 company-sponsored studies are ongoing.

Extended Follow-up Phase 3 Data Underscore Sustained Efficacy and Safety of IMBRUVICA® (ibrutinib) in the Treatment of Chronic Lymphocytic Leukemia (CLL)

Sat December 7, 2019 7:33 AM|PR Newswire|About: ABBV

- New integrated analysis of up to six years of follow-up from RESONATE™ and RESONATE-2 studies (abstract #3054) demonstrated improved results with earlier IMBRUVICA use in CLL patients new to treatment

- Data featured at the 2019 American Society of Hematology (ASH) Annual Meeting further supports IMBRUVICA as the most comprehensively studied Bruton's tyrosine kinase inhibitor, with 10 FDA approvals and 170,000 patients treated worldwide

PR Newswire

NORTH CHICAGO, Ill., Dec. 7, 2019 /PRNewswire/ -- AbbVie (ABBV)

https://seekingalpha.com/pr/17721323-extended-follow-up-phase-3-data-underscore-sustained-efficacy-and-safety-of-imbruvica

July 11, 2018 AbbVie Provides Update on Phase 3 Study of Ibrutinib (IMBRUVICA®) in Blood Cancer Diffuse Large B-Cell Lymphoma (DLBCL) and Ongoing Ibrutinib Clinical Program

IMBRUVICA® (ibrutinib)

- Nearly half of all R/R MCL patients in the pooled analysis were able to survive their disease at three years and more than one quarter of patients had no progression in their disease
- Median PFS outcomes were observed to be higher in patients who received ibrutinib earlier and after only one prior therapy
- This analysis comprises of 3.5 years of R/R MCL follow-up data, the longest to date in Bruton's tyrosine kinase (BTK) inhibition
- This press release corresponds to abstract #151

https://www.nejm.org/doi/full/10.1056/NEJMoa1306220#t=article

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00667-4/fulltext

December 9, 2017 IMBRUVICA® (ibrutinib) Pooled Analysis Suggests Benefit in Progression-Free Survival (PFS) at 3.5 Years in Patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL)

U.S. FDA Approval of IMBRUVICA® (ibrutinib) Plus Obinutuzumab (GAZYVA®)

- Milestone marks the 10th FDA approval for IMBRUVICA in six different disease areas since 2013
- FDA approval is based on positive Phase 3 iLLUMINATE (PCYC-1130) study results, which demonstrated IMBRUVICA plus obinutuzumab significantly prolonged progression-free survival versus the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines Category 1 treatment of chlorambucil plus obinutuzumab
- FDA also approved an updated IMBRUVICA label to include additional long-term efficacy data

NORTH CHICAGO, Ill., Jan. 28, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV),

https://www.hematology.org/Patients/Cancers/Leukemia.aspx

https://www.leukaemia.org.au/disease-information/lymphomas/non-hodgkin-lymphoma/other-non-hodgkin-lymphomas/small-lymphocytic-lymphoma/

https://ghr.nlm.nih.gov/condition/isolated-growth-hormone-deficiency

https://www.gazyva.com/

January 28, 2019 AbbVie Announces U.S. FDA Approval of IMBRUVICA® (ibrutinib) Plus Obinutuzumab (GAZYVA®) - First Chemotherapy-Free, Anti-CD20 Combination Regimen Approved for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) in Previously Untreated Patients

IMBRUVICA® (ibrutinib) in Combination with Rituximab

Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA Seeking Approval of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia

Fri November 8, 2019 7:35 AM|PR NewswirePR Newswire

RARITAN, N.J., Nov. 8, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

https://www.prnewswire.com/news-releases/janssen-announces-submission-of-supplemental-new-drug-application-to-us-fda-seeking-approval-of-imbruvica-ibrutinib-in-combination-with-rituximab-for-previously-untreated-patients-with-chronic-lymphocytic-leukemia-300954520.html

https://www.nejm.org/doi/full/10.1056/NEJMoa1817073

https://imbruvica.com/files/prescribing-information.pdf

https://www.janssen.com/

https://www.imbruvica.com/

Janssen Announces Submission of Supplemental New Drug Application to U.S. FDA Seeking Approval of IMBRUVICA® (ibrutinib) in Combination with Rituximab for Previously Untreated Patients with Chronic Lymphocytic Leukemia Fri November 8, 2019 7:35 AM|PR Newswire PR Newswire RARITAN, N.J., Nov. 8, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson

IMBRUVICA® (ibrutinib) Combination Regimen

- Results from this interim analysis showed ibrutinib plus rituximab prolonged progression-free survival (PFS) compared to a standard chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR) at nearly 3 years of follow-up (abstract #LBA-4)
- The data also showed an improved overall survival (OS) for CLL patients treated with IMBRUVICA plus rituximab versus FCR
- First head-to-head trial of an IMBRUVICA-based, chemotherapy-free combination regimen versus FCR and dedicated to CLL patients aged 70 years or younger
- Study results were presented at the Late Breaking session at ASH 2018

NORTH CHICAGO, Ill., Dec. 4, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV)

December 4, 2018 IMBRUVICA® (ibrutinib) Combination Regimen Significantly Improved Survival Versus the Chemoimmunotherapy FCR (Fludarabine, Cyclophosphamide and Rituximab) in Previously Untreated and Younger Chronic Lymphocytic Leukemia (CLL) Patients; Late-Breaking Phase 3 Data at ASH 2018

Tecentriq® (atezolizumab) Tecentriq® +Avastin® (bevacizumab

Tecentriq in Combination With Avastin Increased Overall Survival

Genentech Presents Pivotal Data Demonstrating Tecentriq in Combination With Avastin Improves Overall Survival in People With the Most Common Form of Liver Cancer

– First Phase III cancer immunotherapy study to show an improvement in overall survival and progression-free survival in people with unresectable hepatocellular carcinoma compared with sorafenib –

– Results will be presented in the Presidential session at the European Society for Medical Oncology (ESMO) Asia Congress 2019 –

November 22, 2019 11:05 AM Eastern Standard Time

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY

https://www.businesswire.com/news/home/20191122005376/en/

https://www.gene.com/

https://www.gene.com/topics/cancer-immunotherapy

https://www.avastin.com/

https://www.tecentriq.com/

https://seekingalpha.com/pr/17708936-genentech-presents-pivotal-data-demonstrating-tecentriq-combination-avastin-improves-overall

China National Medical Products Administration grants approval of Roche’s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung cancer

This marks the first approval for a Tecentriq-based therapy in China, less than a year after the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals in this indication
Tecentriq with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy combination approved for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC)
The combination significantly improved overall survival (OS) and progression-free survival (PFS) for the first time in over 20 years

Basel, 14 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY)

https://www.roche.com/media/releases/med-cor-2020-02-14.htm

Genentech’s Tecentriq in Combination With Avastin Increased Overall Survival and Progression-free Survival in People With Unresectable Hepatocellular Carcinoma

https://www.businesswire.com/news/home/20191020005095/en/

https://www.gene.com/media/press-releases/14818/2019-10-20/genentechs-tecentriq-in-combination-with

https://www.tecentriq.com/

https://www.avastin.com/

https://www.gene.com/topics/cancer-immunotherapy

https://www.tecentriq-hcp.com/

Genentech Submits Supplemental Biologics License Application to the FDA for Tecentriq in Combination With Avastin for the Most Common Form of Liver Cancer

Mon January 27, 2020 1:00 AM|Business Wire|About: RHHBY

– Application is being reviewed under FDA's Real-Time Oncology Review pilot program –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

https://www.gene.com/media/press-releases/14835/2020-01-26/genentech-submits-supplemental-biologics

https://seekingalpha.com/pr/17759267-genentech-submits-supplemental-biologics-license-application-to-fda-for-tecentriq-in

Genentech Announces Phase III Study Results for Tecentriq Plus Cotellic and Zelboraf in People With Previously Untreated BRAF V600 Mutation-positive Advanced Melanoma

Fri December 13, 2019 1:00 AM|Business Wire|About: RHHBY

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

https://seekingalpha.com/pr/17727566-genentech-announces-phase-iii-study-results-for-tecentriq-plus-cotellic-and-zelboraf-in

COTELLIC is a prescription medicine that is used with the medicine ZELBORAF, to treat a type of skin cancer called melanoma:

that has spread to other parts of the body or cannot be removed by surgery, and
that has a certain type of abnormal “BRAF” gene

https://www.cotellic.com/

ZELBORAF® (VEMURAFENIB)

https://www.gene.com/patients/medicines/zelboraf

Genentech’s Tecentriq in Combination With Avastin Increased Overall Survival and Progression-free Survival in People With Unresectable Hepatocellular Carcinoma Mon October 21, 2019 1:00 AM|Business Wire|About: RHHBY – First Phase III cancer immunotherapy study to show an improvement in overall survival and progression-free survival for the treatment of the most common form of liver cancer – – Data will be submitted to health authorities globally, including the U.S. Food and Drug Administration (FDA) – SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)

Genentech Presents Positive Phase III Results for Tecentriq

Genentech Presents Positive Phase III Results for Tecentriq (Atezolizumab) in Combination With Platinum-Based Chemotherapy in People With Previously Untreated Advanced Bladder Cancer

https://www.tecentriq-hcp.com/

https://www.gene.com/

Monday, Sep 30, 2019 Genentech Presents Positive Phase III Results for Tecentriq (Atezolizumab) in Combination With Platinum-Based Chemotherapy in People With Previously Untreated Advanced Bladder Cancer IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in people with previously untreated advanced bladder cancer Tecentriq combination reduced the risk of disease worsening or death (progression-free survival) compared with chemotherapy alone Data will be presented today at the 2019 European Society for Medical Oncology (ESMO) Congress South San Francisco, CA -- September 30, 2019 --

Genentech’s Tecentriq (Atezolizumab) as a First-Line Monotherapy

Genentech’s Tecentriq (Atezolizumab) as a First-Line Monotherapy Helped Certain People With Advanced Non-Small Cell Lung Cancer Live Longer Compared With Chemotherapy

https://www.tecentriq-hcp.com/

Wednesday, Sep 11, 2019 Genentech’s Tecentriq (Atezolizumab) as a First-Line Monotherapy Helped Certain People With Advanced Non-Small Cell Lung Cancer Live Longer Compared With Chemotherapy Data will be shared with health authorities globally, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) South San Francisco, CA -- September 11, 2019 --

FDA granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane®

GENENTECH MEDICINE FDA APPROVED AS FIRST CANCER IMMUNOTHERAPY FOR A TYPE OF BREAST CANCER

March 8th, 2019

On March 8, 2019, the FDA granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

https://www.tecentriq-hcp.com/

https://www.abraxane.com/

https://media.celgene.com/content/uploads/abraxane-pi.pdf

GENENTECH MEDICINE FDA APPROVED AS FIRST CANCER IMMUNOTHERAPY FOR A TYPE OF BREAST CANCER March 8th, 2019 On March 8, 2019, the FDA granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express PD-L1, as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

ABRAXANE is a prescription medicine used to treat:  advanced breast cancer in people who have already received certain other medicines for their cancer.  advanced non-small cell lung cancer, in combination with carboplatin in people who cannot be treated with surgery or radiation.  advanced pancreatic cancer, when used in combination with gemcitabine as the first medicine for advanced pancreatic cancer.

CANCER IMMUNOTHERAPY

LYNPARZA® (olaparib)

LYNPARZA (olaparib) more than doubled the time without radiographic disease progression in patients with BRCA1/2- or ATM-mutated metastatic castration-resistant prostate cancer

PUBLISHED30 September 2019

AstraZeneca and Merck’s LYNPARZA reduced the risk of disease progression or death by 51% in men with homologous recombination repair (HRR) gene mutations

First positive Phase III trial testing a targeted treatment in biomarker-selected prostate cancer patients

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada)

LYNPARZA (olaparib) More Than Doubled the Time Without Radiographic Disease Progression in Patients With BRCA1/2- or ATM-Mutated Metastatic Castration-Resistant Prostate Cancer

Mon September 30, 2019 10:59 AM|Business Wire|About: AZN

https://seekingalpha.com/pr/17647768-lynparza-olaparib-doubled-time-without-radiographic-disease-progression-patients-brca1-2-atm

https://www.businesswire.com/news/home/20190930005570/en/

https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf#page=1

https://www.astrazeneca-us.com/content/az-us/media/press-releases/2019/lynparza-olaparib-more-than-doubled-the-time-without-radiographic-disease-progression-in-patients-with-brca12-or-atm-mutated-metastatic-castration-resistant-prostate-cancer-09302019.html

https://www.lynparza.com/

LYNPARZA (olaparib) more than doubled the time without radiographic disease progression in patients with BRCA1/2- or ATM-mutated metastatic castration-resistant prostate cancer

LYNPARZA (olaparib)

LYNPARZA (olaparib) improved the time women lived without disease progression to 22 months in the broad population and to 37 months in hrd-positive patients as 1st-line maintenance treatment with bevacizumab for newly diagnosed advanced ovarian cancer

PUBLISHED28 September 2019

AstraZeneca and Merck’s LYNPARZA added to bevacizumab reduced the risk of disease progression or death by 41% in the overall trial population

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada

https://www.astrazeneca-us.com/

https://www.astrazeneca.com/search-results.s.html?q=LYNPARZA+

https://www.astrazeneca.com/our-therapy-areas/oncology.html

https://www.lynparza.com/ovarian-cancer/ovarian-cancer-treatment.html

LYNPARZA (olaparib) improved the time women lived without disease progression to 22 months in the broad population and to 37 months in hrd-positive patients as 1st-line maintenance treatment with bevacizumab for newly diagnosed advanced ovarian cancer

LYNPARZA® (olaparib)

https://www.businesswire.com/news/home/20191205005115/en/

LYNPARZA® (olaparib) Approved in China as a First-Line Maintenance Therapy in BRCA-Mutated (BRCAm) Advanced Ovarian Cancer

AstraZeneca and Merck’s LYNPARZA Reduced the Risk of Disease Progression or Death by 70% Versus Placebo in BRCAm Advanced Ovarian Cancer Following Response to Platinum-Based Chemotherapy

Only PARP Inhibitor Approved in This Setting in China

Thursday, December 5, 2019 6:45 am EST

https://www.mrknewsroom.com/news-release/oncology/lynparza-olaparib-approved-china-first-line-maintenance-therapy-brca-mutated-b

https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf#page=1

LYNPARZA is a prescription medicine used to treat adults who have:

advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy
advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you

https://www.lynparza.com/ovarian-cancer/recurrent-ovarian-cancer.html#isi

LYNPARZA® (olaparib) Approved in China as a First-Line Maintenance Therapy in BRCA-Mutated (BRCAm) Advanced Ovarian Cancer Thu December 5, 2019 6:45 AM|Business Wire|About: MRK AstraZeneca and Merck’s LYNPARZA Reduced the Risk of Disease Progression or Death by 70% Versus Placebo in BRCAm Advanced Ovarian Cancer Following Response to Platinum-Based Chemotherapy Only PARP Inhibitor Approved in This Setting in China KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK), known as MSD outside the United States and Canada,

LYNPARZA® (olaparib) Recommended by FDA Advisory Committee for First-Line Maintenance Therapy in Germline BRCA-Mutated Metastatic Pancreatic Cancer That Has Not Progressed on Platinum-Based Chemotherapy

Oncologic Drugs Advisory Committee Voted That LYNPARZA Demonstrated a Favorable Benefit-Risk Profile for Patients Based on Phase 3 POLO Trial Results

December 17, 2019 02:09 PM Eastern Standard Time

KENILWORTH, N.J.--(BUSINESS WIRE)--AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada,

https://www.businesswire.com/news/home/20191217005774/en/

LYNPARZA® (olaparib) Recommended by FDA Advisory Committee for First-Line Maintenance Therapy in Germline BRCA-Mutated Metastatic Pancreatic Cancer That Has Not Progressed on Platinum-Based Chemotherapy

Oncologic Drugs Advisory Committee Voted That LYNPARZA Demonstrated a Favorable Benefit-Risk Profile for Patients Based on Phase 3 POLO Trial Results

Tuesday, December 17, 2019 2:09 pm EST

https://www.mrknewsroom.com/news-release/oncology/lynparza-olaparib-recommended-fda-advisory-committee-first-line-maintenance-th

https://www.lynparza.com/#isi

Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer

PUBLISHED17 December 2019

17 December 2019 18:00 GMT

ODAC voted that Lynparza demonstrated a clinically meaningful and favourable
risk-benefit profile for patients based on Phase III POLO trial results

AstraZeneca and MSD Inc., Kenilworth, NJ, US (MSD: known as Merck & Co., Inc. inside the US and Canada)

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/lynparza-recommended-by-fda-advisory-committee-for-1st-line-maintenance-treatment-of-germline-brca-mutated-metastatic-pancreatic-cancer.html

LYNPARZA® (olaparib) Recommended by FDA Advisory Committee for First-Line Maintenance Therapy in Germline BRCA-Mutated Metastatic Pancreatic Cancer That Has Not Progressed on Platinum-Based Chemotherapy Tue December 17, 2019 2:09 PM|Business Wire|About: MRK Oncologic Drugs Advisory Committee Voted That LYNPARZA Demonstrated a Favorable Benefit-Risk Profile for Patients Based on Phase 3 POLO Trial Results KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK), known as MSD outside the United States and Canada,

Lynparza approved in the US 1st-line treatment of germline BRCA-mutated metastatic pancreatic cancer

Lynparza approved in the US as a 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer

PUBLISHED30 December 2019

30 December 2019 07:00 GMT

Lynparza reduced the risk of disease progression or death by 47% in patients
whose disease had not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen

Only PARP inhibitor approved in germline BRCA-mutated
metastatic pancreatic cancer

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2019/lynparza-approved-in-the-us-as-a-1st-line-maintenance-treatment-of-germline-brca-mutated-metastatic-pancreatic-cancer-30122019.html

LYNPARZA (Olaparib) Approved in the US as a 1st-line Maintenance Treatment of Germline BRCA-mutated Metastatic Pancreatic Cancer Mon December 30, 2019 6:55 AM|Business Wire|About: AZN LYNPARZA reduced the risk of disease progression or death by 47% in patients whose disease had not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen Only PARP inhibitor approved in germline BRCA-mutated metastatic pancreatic cancer WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada)

SEEKING BIOTECH ALPHA = BIOTECMAX THE HEART OF BIOTEC 6/25/2024

VENCLEXTA®/ VENCLYXTO® (venetoclax)

Venclexta-based Treatments in Chronic Lymphocytic Leukemia Sun December 8, 2019 7:30 AM RHHBY

New Long-Term Data Continues to Demonstrate Progression-Free Survival and Overall Survival Benefits with VENCLEXTA®/ VENCLYXTO® (venetoclax) Combination in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Venclexta-based Treatments in Chronic Lymphocytic Leukemia

VENCLYXTO® (venetoclax) in combination with obinutuzumab

AbbVie Receives European Commission Approval of VENCLYXTO® Combination Regimen for Patients with Previously-Untreated Chronic Lymphocytic Leukemia

XTANDI® (enzalutamide)

XTANDI® (enzalutamide)

Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA)

Astellas Announces the Approval of XTANDI® (enzalutamide) by the China National Medical Products Administration (NMPA) Approval based on Asian PREVAIL study of men with metastatic castration-resistant prostate cancer

XTANDI® (enzalutamide)

XTANDI can slow advanced prostate cancer progression while you focus more on what you love

XTANDI® (enzalutamide) Approved by U.S. FDA for the Treatment of Metastatic Castration-Sensitive Prostate Cancer

XTANDI® (enzalutamide)

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (PROSPER)

VUMERITY™ (diroximel fumarate)

VUMERITY™ (diroximel fumarate)

Biogen Presents Data Demonstrating Improved Gastrointestinal Tolerability With VUMERITY™ (diroximel fumarate) Compared to TECFIDERA® (dimethyl fumarate)

BIOGEN PRESENTS DATA DEMONSTRATING IMPROVED GASTROINTESTINAL TOLERABILITY WITH VUMERITY™ (DIROXIMEL FUMARATE) COMPARED TO TECFIDERA® (DIMETHYL FUMARATE)

VUMERITY™ (diroximel fumarate)

NOW APPROVED

Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYX

Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®)

AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting

ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) chronic lymphocytic leukemia (CLL)

AbbVie to Present Latest Clinical Research in the Treatment of Leukemias, Lymphomas and Other Blood Cancers at 2019 ASH Annual Meeting

Ibrutinib (IMBRUVICA®)

VENCLEXTA®/VENCLYXTO® (venetoclax)

IMBRUVICA® (ibrutinib) Plus VENCLEXTA®/VENCLYXTO® (venetoclax) Combination Data Show High Rates of Disease Clearance in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL)

REVLIMID® (lenalidomide) in combination with rituximab (R²

REVLIMID® (lenalidomide) in combination with rituximab (R²)

Celgene Receives CHMP Positive Opinion for REVLIMID® (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously Treated Follicular Lymphoma

REVLIMID® (lenalidomide) in combination with rituximab (R²)

INDICATIONS

REVLIMID® (lenalidomide) in combination with rituximab (R²)

Celgene Receives CHMP Positive Opinion for REVLIMID® (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously Treated Follicular Lymphoma

Revlimid® (lenalidomide) in Combination with Rituximab

Bristol-Myers Squibb Receives European Commission Approval for Revlimid® (lenalidomide) in Combination with Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma

REVLIMID® (lenalidomide)

BeiGene Announces Acceptance of a Supplemental New Drug Application in China for REVLIMID® in Relapsed or Refractory Indolent Lymphoma

ERVEBO®

Merck’s ERVEBO® [Ebola Zaire Vaccine Granted Conditional Approval in the European Union

Ervebo

ERVEBO® (Ebola Zaire Vaccine, Live) Now Registered in Four African Countries, Within 90 Days of Reference Country Approval and WHO Prequalification

Ebola vaccine approved in Europe in landmark moment in fight against a deadly disease

Merck’s ERVEBO® [Ebola Zaire Vaccine Granted Conditional Approval in the European Union

First FDA-approved vaccine for the prevention of Ebola virus disease

First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

FDA OKs Merck Ebola vaccine

Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live)

Home/Emergencies/Diseases/Ebola/Ebola health update - DRC, 2019

KEYTRUDA® (pembrolizumab) KEYTRUDA® +LENVIMA® (lenvatinib

KEYTRUDA® (pembrolizumab)= Metastatic or Unresectable Recurrent Head & Neck Squamous Cell Carcinoma

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer With Carcinoma In Situ With or Without Papillary Tumors Who Are Ineligible for or Have Elected Not to Undergo Cystectomy

Merck Receives Positive EU CHMP Opinion for Two New Regimens of KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma

FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

European Commission Approves Two New Regimens of Merck’s KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

European Commission Approves Two New Regimens of Merck’s KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

Merck’s KEYTRUDA® (pembrolizumab) Now Approved as Monotherapy in China for First-Line Treatment of Certain Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express PD-L1

KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib)

FDA Approves KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma

FDA Approves LENVIMA® (lenvatinib) plus KEYTRUDA® (pembrolizumab) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma

FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Showed Statistically Significant Increase in Pathological Complete Response Versus Chemotherapy as Neoadjuvant Therapy in Early-Stage Triple-Negative Breast Cancer (TNBC)

Keytruda Set to Become World’s Top-Selling Drug,

Keytruda Approvals: A Timeline

Marks First Approval for KEYTRUDA in SCLC

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Monotherapy for Patients with Metastatic Small Cell Lung Cancer (SCLC) with Disease Progression on or After Platinum-Based Chemotherapy and at Least One Other Prior Line of Therapy

Opdivo (nivolumab) OPDIVO + YERVOY® (ipilimumab)

European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab)

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) for Patients with Hepatocellular Carcinoma (HCC) Previously Treated with Sorafenib

U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination for Patients with Previously Treated Advanced Hepatocellular Carcinoma

CATEGORY:

Opdivo demonstrated a 23% reduction in the risk of death overall survival compared to chemotherapy

Opdivo (nivolumab) Demonstrates Statistically Significant Overall Survival Benefit Versus Chemotherapy in Patients with Advanced Esophageal Cancer

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab)

Bristol-Myers Squibb Announces Pooled Five-Year Survival Results for Opdivo (nivolumab) in Previously-Treated Advanced Non-Small Cell Lung Cancer Patients

Data exploring potential of Opdivo & Opdivo plus Yervoy in esophageal, cervical and prostate cancer