Moorestown, New Jersey, United States
BIOTECNOVA™
BIOTECNOVA™ - Second Group Page
BIOTECNOVA™ -First Group Page
BIOTECNOVA™
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) as First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1≥1%
Fri May 15, 2020 3:56 PM|Business Wire|About: BMY
In CheckMate -227 Part 1a, Opdivo + Yervoy showed superior and durable long-term overall survival versus chemotherapy1,2,3
Fifth indication for Opdivo + Yervoy, the first and only FDA-approved dual immunotherapy
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY)
https://www.yervoy.com/metastatic
https://www.businesswire.com/news/home/20200515005557/en/
OPDIVO® Immunotherapy: Giving People a Choice and a Chance Against Their Cancer
BACK
ADVANCED LUNG CANCER
- OPDIVO for people who have had prior treatments for non-small cell lung cancer
- OPDIVO for people who have had prior treatments for small cell lung cancer
- Advanced Lung Cancer
- Advanced Kidney Cancer
- Advanced Liver Cancer
- Colorectal Cancer (MSI-H/dMMR)
- Melanoma
- Head and Neck Squamous Cell Cancer
- Advanced Bladder Cancer
- Classical Hodgkin Lymphoma
Tecentriq® (atezolizumab)
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Monday, May 18, 2020
FDA Approves Genentech’s Tecentriq as a First-Line Monotherapy for Certain People With Metastatic Non-Small Cell Lung Cancer
Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall
Approval based on the Phase III IMpower110 study showing Tecentriq demonstrated a significant overall survival benefit in people with high PD-L1 expression compared with chemotherapy
South San Francisco, CA -- May 18, 2020 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
https://www.businesswire.com/news/home/20200518005690/en/
https://www.gene.com/topics/cancer-immunotherapy
FDA Approves Genentech’s Tecentriq as a First-Line Monotherapy for Certain People With Metastatic Non-Small Cell Lung Cancer
Mon May 18, 2020 3:30 PM|Business Wire|About: RHHBY
– Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall –
– Approval based on the Phase III IMpower110 study showing Tecentriq demonstrated a significant overall survival benefit in people with high PD-L1 expression compared with chemotherapy –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY)
https://seekingalpha.com/symbol/RHHBY
LYNPARZA® (olaparib)
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
LYNPARZA® (olaparib)
LYNPARZA® (Olaparib) Approved in the US for HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
Wed May 20, 2020 7:00 AM|Business Wire|About: AZN
Only PARP inhibitor to improve overall survival vs enzalutamide or abiraterone in the biomarker-based subset of prostate cancer patients with BRCA1/2 or ATM mutations
Approximately 20-30% of men with mCRPC have an HRR gene-mutation
WILMINGTON, Del.--(BUSINESS WIRE)--
AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (Merck: known as MSD outside the US and Canada)
Please click here for complete Prescribing Information, including Patient Information (Medication Guide).
https://www.astrazeneca-us.com/
https://www.businesswire.com/news/home/20200520005224/en/
https://seekingalpha.com/symbol/AZN
https://seekingalpha.com/symbol/MRK
https://seekingalpha.com/symbol/AZN
LYNPARZA® (olaparib)
BIOTECNOVA™
VENCLEXTA® (venetoclax) with Obinutuzumab
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
AbbVie Receives Health Canada Approval for the Combination of VENCLEXTA® (venetoclax) with Obinutuzumab for Patients with Previously Untreated Chronic Lymphocytic Leukemia
Tue May 5, 2020 7:01 AM|Canada Newswire|About: ABBV
- VENCLEXTA® (venetoclax) plus obinutuzumab is the first chemotherapy-free, fixed-duration combination regimen approved by Health Canada 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 VENCLEXTA had clinically meaningful and statistically significant 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
MONTREAL, May 5, 2020 /CNW/ - AbbVie (ABBV), a research-based global biopharmaceutical company, announced today that Health Canada has approved VENCLEXTA® (venetoclax) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL).
https://seekingalpha.com/symbol/ABBV
https://seekingalpha.com/news/3568997-abbvies-venclexta-okd-in-canada-for-first-line-cll
https://seekingalpha.com/symbol/RHHBY
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy in First-Line Lung Cancer
FDA application granted Priority Review designation with PDUFA date of August 6, 2020
Submissions based on results from Phase 3 CheckMate -9LA trial
CATEGORY:
CORPORATE/FINANCIAL NEWSWEDNESDAY, APRIL 8, 2020 6:59 AM EDT
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE:BMY)
Remdesivir (GS-5734, Nuc inhibitor
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Remdesivir (GS-5734, Nuc inhibitor
An Open Letter from our Chairman and CEO
Daniel O’Day - March 28, 2020
Gilead Generates Street Skepticism Ahead of Covid-19 Results
By Cristin FlanaganApril 7, 2020, 7:34 AM EDT Updated on April 7, 2020, 10:03 AM EDT
- Remdesivir China data expected this month, U.S. results in May
- Barclays sees 20% chance that Chinese studies will succeed
Bottles of Remdesivir at a hospital in Wuhan, China, in Feb. Photographer: Yuan Zheng
— With assistance by Gregory Calderone
Bloomberg
Working to Supply Remdesivir for COVID-19
Army signs agreement with drug giant Gilead on experimental COVID-19 treatment
Patricia KimeMarch 10
https://mp.weixin.qq.com/s/CMSi5JhG1T0kZb0DNgzAhw
https://www.nasdaq.com/market-activity/stocks/gild/dividend-history
Data for Gilead’s potential coronavirus therapy are coming soon. Here’s what you need to know
By ANDREW JOSEPH @DrewQJoseph, ADAM FEUERSTEIN @adamfeuerstein, DAMIAN GARDE @damiangarde, and MATTHEW HERPER @matthewherper
APRIL 6, 2020
https://www.statnews.com/2020/04/06/gilead-remdesivir-data-coming-soon/
Science 14:56, 06-Mar-2020
Translate
Interview with Chinese respiratory disease expert: Clinical drug trials for COVID-19 going smoothly
Updated 18:49, 06-Mar-2020
By Xu Zhaoqun and Dai Piaoyi
FARXIGA® (dapagliflozin)
BRAFTOVI® (Encorafenib) in Combination w/ Cetuximab = BRAFV600E-Mutant Metastatic Colorectal Cancer
Remdesivir (GS-5734, Nuc inhibitor
Farxiga Phase III DAPA-CKD trial will be stopped early after overwhelming efficacy in patients with chronic kidney disease
PUBLISHED30 March 2020
30 March 2020 07:00 BST
Farxiga is the first SGLT2 inhibitor to show meaningful benefit in patients with chronic kidney disease in a trial including both type-2 diabetics and non-diabetics
Farxiga reduced the incidence of heart failure worsening or cardiovascular death in a sub-analysis from landmark Phase III DAPA-HF trial
https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/farxiga-reduced-the-incidence-of-heart-failure-worsening-or-cardiovascular-death-in-a-sub-analysis-from-landmark-phase-iii-dapa-hf-trial.html
https://seekingalpha.com/pr/17821565-farxiga-reduced-incidence-of-heart-failure-worsening-cardiovascular-death-in-sub-analysis
https://seekingalpha.com/symbol/AZN
https://www.astrazeneca.com/
BRAFTOVI® (Encorafenib) in Combination w/ Cetuximab = BRAFV600E-Mutant Metastatic Colorectal Cancer
BRAFTOVI® (Encorafenib) in Combination w/ Cetuximab = BRAFV600E-Mutant Metastatic Colorectal Cancer
BRAFTOVI® (Encorafenib) in Combination w/ Cetuximab = BRAFV600E-Mutant Metastatic Colorectal Cancer
U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy
Wed April 8, 2020 6:27 PM|Business Wire|About: PFE
BRAFTOVI plus cetuximab is the first-and-only FDA-approved targeted regimen specifically for adults with previously treated metastatic CRC with a BRAFV600E mutation
NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®)
https://www.businesswire.com/news/home/20200408005791/en/
https://seekingalpha.com/symbol/PFE
ERBITUX® (cetuximab)
Libtayo® (cemiplimab)
BRAFTOVI® (Encorafenib) in Combination w/ Cetuximab = BRAFV600E-Mutant Metastatic Colorectal Cancer
BRAFTOVI® (Encorafenib) in Combination w/ Cetuximab = BRAFV600E-Mutant Metastatic Colorectal Cancer
https://clinicaltrials.gov/ct2/show/NCT03132636?cond=Basal+Cell+Carcinoma&lead=regeneron&draw=2&rank=1 May 5, 2020 at 12:59 AM EDT
LIBTAYO® (CEMIPLIMAB) SHOWS CLINICALLY-MEANINGFUL AND DURABLE RESPONSES IN SECOND-LINE ADVANCED BASAL CELL CARCINOMA
TARRYTOWN, N.Y. and PARIS, May 5, 2020 /PRNewswire/ --
Objective responses seen in approximately 29% of patients with locally advanced basal cell carcinoma (BCC)
In a preliminary analysis, objective responses seen in 21% of patients with metastatic BCC
Approximately 85% of patients who responded to Libtayo maintained their response for at least one year
Regeneron and Sanofi plan regulatory submissions in 2020
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi
Libtayo® (cemiplimab) shows clinically meaningful and durable responses in second-line advanced basal cell carcinoma
Tue May 5, 2020 1:00 AM|GlobeNewswire|About: SNY
Libtayo® (cemiplimab) shows clinically meaningful and durable responses in second-line advanced basal cell carcinoma
- Objective responses seen in 29% of patients with locally advanced basal cell carcinoma (BCC)
- In a preliminary analysis, objective responses seen in 21% of patients with metastatic BCC
- Approximately 85% of patients who responded to Libtayo maintained their response for at least one year
- Sanofi (SNY) and Regeneron plan regulatory submissions in 2020
Paris and Tarrytown, NY – May 5, 2020 - Topline data for a pivotal, single-arm, open-label trial for Sanofi and Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab)
https://seekingalpha.com/symbol/SNY
https://seekingalpha.com/symbol/REGN
PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
Regeneron and Sanofi's Libtayo shows benefit in skin cancer
May 5, 2020 6:42 AM ET|About: Regeneron Pharmaceutic... (REGN)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3568922-regeneron-and-sanofis-libtayo-shows-benefit-in-skin-cancer
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Bristol Myers Squibb and Exelixis Announce Positive Topline Results from Pivotal Phase 3 CheckMate -9ER Trial Evaluating Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib) in Previously Untreated Advanced Renal Cell Carcinoma
Mon April 20, 2020 6:59 AM|Business Wire|About: BMY, EXEL
Study met primary endpoint of significantly improving progression-free survival, and secondary endpoints of overall survival and objective response rate vs. sunitinib
Opdivo in combination with CABOMETYX demonstrates clinically meaningful efficacy results across all endpoints and preliminary assessment showing a favorable safety profile
PRINCETON, N.J. & ALAMEDA, Calif.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (EXEL) (NASDAQ: EXEL)
A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER)
https://clinicaltrials.gov/ct2/show/NCT03141177?term=checkmate-9er&draw=2&rank=1
https://www.businesswire.com/news/home/20200420005248/en/
https://seekingalpha.com/symbol/EXEL
https://seekingalpha.com/symbol/BMY
Opdivo/Cabometyx combo successful in first-line kidney cancer
Apr. 20, 2020 7:19 AM ET|About: Bristol-Myers Squibb C... (BMY)|By: Douglas W. House, SA News Editor
https://seekingalpha.com/news/3561978-opdivo-cabometyx-combo-successful-in-first-line-kidney-cancer
IMBRUVICA® (ibrutinib) Receives 11th FDA Approval
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
IMBRUVICA® (ibrutinib) Receives 11th FDA Approval
Tue April 21, 2020 3:22 PM|PR Newswire|About: ABBV
- This milestone marks the fifth study for IMBRUVICA to bring a chemo-free treatment option to patients with CLL and the sixth approval for IMBRUVICA in CLL
- Granted under FDA's Real-Time Oncology Review pilot program, Project Orbis and priority review
- IMBRUVICA has been used to treat more than 195,000 patients worldwide across approved indications
PR Newswire
NORTH CHICAGO, Ill., April 21, 2020 /PRNewswire/ -- AbbVie (ABBV)
https://seekingalpha.com/symbol/ABBV
https://seekingalpha.com/symbol/RHHBY
Farxiga (dapagliflozin)
Opdivo® (nivolumab) in Combination with CABOMETYX® (cabozantinib)
Farxiga (dapagliflozin)
Farxiga approved in the US for the treatment of heart failure in patients with heart failure with reduced ejection fraction
PUBLISHED6 May 2020
6 May 2020 07:00 BST
Farxiga is the first SGLT2 inhibitor proven to significantly reduce
the risk of cardiovascular death and hospitalisation for heart failure
AstraZeneca’s Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalisation for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D).
https://www.nejm.org/doi/full/10.1056/NEJMoa1911303?query=main_nav_lg
https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-type-heart-failure
https://seekingalpha.com/symbol/AZN
LYNPARZA® (olaparib)
Retevmo™ (selpercatinib)
Farxiga (dapagliflozin)
LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer
Fri May 8, 2020 5:25 PM|Business Wire|About: MRK
Improved the Median Time to Disease Progression (37.2 months) vs. Bevacizumab Alone (17.7 months) Following Response to Platinum-Based Chemotherapy with Bevacizumab
Approximately One in Two Women with Advanced Ovarian Cancer Has an HRD-Positive Tumor
KENILWORTH, N.J.--(BUSINESS WIRE)-- AstraZeneca and Merck (MRK)
https://www.businesswire.com/news/home/20200508005523/en/
https://www.merck.com/index.html
https://www.merck.com/clinical-trials/index.html
https://www.azpicentral.com/lynparza_tb/lynparza_tb.pdf#page=1
LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer
Improved the Median Time to Disease Progression (37.2 months) vs. Bevacizumab Alone (17.7 months) Following Response to Platinum-Based Chemotherapy with Bevacizumab
Approximately One in Two Women with Advanced Ovarian Cancer Has an HRD-Positive Tumor
Friday, May 8, 2020 5:25 pm EDT
https://seekingalpha.com/symbol/MRK
https://seekingalpha.com/symbol/AZN
Retevmo™ (selpercatinib)
Retevmo™ (selpercatinib)
Retevmo™ (selpercatinib)
Lilly Receives U.S. FDA Approval for Retevmo™ (selpercatinib), the First Therapy Specifically for Patients with Advanced RET-Driven Lung and Thyroid Cancers
05/08/2020Download PDF- Approved for metastatic RET fusion-positive NSCLC, advanced or metastatic RET-mutant MTC and advanced or metastatic RET fusion-positive thyroid cancer
- Accelerated approval based on data from LIBRETTO-001 Phase 1/2, largest trial ever reported in patients with RET-driven cancers
- Registrational data demonstrated durable objective responses and showed high intracranial response rate in patients with NSCLC that has spread to the brain
INDIANAPOLIS, May 8, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY)
FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion
May 08, 2020
FDA approves Eli Lilly drug to treat three types of tumors
May 8, 2020 6:57 PM ET|About: Eli Lilly and Company (LLY)|By: Carl Surran, SA News Editor
https://seekingalpha.com/news/3572368-fda-approves-eli-lilly-drug-to-treat-three-types-of-tumors
https://seekingalpha.com/symbol/LLY
Rubraca® (Rucaparib)
Retevmo™ (selpercatinib)
Retevmo™ (selpercatinib)
Rubraca® (Rucaparib) Approved in the U.S. as Monotherapy Treatment for Patients with BRCA1/2-Mutant, Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Been Treated with Androgen Receptor-Directed Therapy and a Taxane-Based Chemotherapy
Fri May 15, 2020 2:30 PM|Business Wire|About: CLVS
Rubraca is the first PARP inhibitor approved in a prostate cancer setting
Accelerated approval based on objective response rate (ORR) and duration of response (DOR) data from the TRITON2 clinical triali
44% ORR (95% CI 31, 57) and median DOR not evaluable (95% CI 6.4, NE, range in months at data cutoff 1.7-24.0+) by blinded independent radiologic review (IRR)i
Most common Grade 3-4 adverse reaction was anemia; most common Grade 3-4 lab abnormality was decrease in hemoglobini
BOULDER, Colo.--(BUSINESS WIRE)-- Clovis Oncology, Inc. (CLVS),
https://rubracaconnections.com/
https://www.clovisoncology.com/
Opdivo (nivolumab) Plus Yervoy (ipilimumab) w/ Chemo
Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy
Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy in First-Line Lung Cancer
Wed April 8, 2020 6:59 AM|Business Wire|About: BMY
FDA application granted Priority Review designation with PDUFA date of August 6, 2020
Submissions based on results from Phase 3 CheckMate -9LA trial
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY)
https://seekingalpha.com/symbol/BMY
https://www.nasdaq.com/market-activity/stocks/azn/dividend-history
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FARXIGA® (dapagliflozin)
FARXIGA® (dapagliflozin)
Farxiga Phase III DAPA-CKD trial will be stopped early after overwhelming efficacy in patients with chronic kidney disease
PUBLISHED30 March 2020
30 March 2020 07:00 BST
Farxiga is the first SGLT2 inhibitor to show meaningful benefit in patients with chronic kidney disease in a trial including both type-2 diabetics and non-diabetics
Farxiga reduced the incidence of heart failure worsening or cardiovascular death in a sub-analysis from landmark Phase III DAPA-HF trial
https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/farxiga-reduced-the-incidence-of-heart-failure-worsening-or-cardiovascular-death-in-a-sub-analysis-from-landmark-phase-iii-dapa-hf-trial.html
https://seekingalpha.com/pr/17821565-farxiga-reduced-incidence-of-heart-failure-worsening-cardiovascular-death-in-sub-analysis
https://seekingalpha.com/symbol/AZN
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BRAFTOVI® (Encorafenib) in Combination with Cetuximab
BRAFTOVI® (Encorafenib) in Combination with Cetuximab
U.S. FDA Approves BRAFTOVI® (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy
Wed April 8, 2020 6:27 PM|Business Wire|About: PFEBRAFTOVI plus cetuximab is the first-and-only FDA-approved targeted regimen specifically for adults with previously treated metastatic CRC with a BRAFV600E mutationNEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®)
https://www.businesswire.com/news/home/20200408005791/en/
https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_braftovi_encorafenib_in_combination_with_cetuximab_for_the_treatment_of_brafv600e_mutant_metastatic_colorectal_cancer_crc_after_prior_therapy
https://seekingalpha.com/symbol/PFE
INDICATIONS AND USAGE
BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) are kinase inhibitors indicated for use in combination for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test.
https://www.braftovimektovi.com/hcp/