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Mektovi

(Binimetinib)

ApprovedSmall molecule

Binimetinib is used to treat certain types of skin cancer called melanoma that have a specific genetic mutation. It works by blocking proteins that help cancer cells grow and is often used in combination with another drug called encorafenib.[2] Mektovi is currently approved and in use across 32 indications[4].[1]

Mektovi is one of 687 small molecule programs targeting Peritoneum Cancer. It is currently in Approved.

32

Indications

81

Total Trials

33

Active Trials

686

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

7

Patents

Pipeline

Status by Indication[4][1]

Indication

Peritoneum CancerApproved

MetastasisActive, not recruiting

Adamantinomatous CraniopharyngiomaActive, not recruiting

Lung CancerActive, not recruiting

Hairy Cell LeukemiaActive, not recruiting

LeukemiaApproved

Metastatic MelanomaActive, not recruiting

Cardiac HypertrophyApproved

Uveal MelanomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Peritoneum CancerApproved

Approved

MetastasisPhase 2

Active, not recruiting

Adamantinomatous CraniopharyngiomaPhase 2

Active, not recruiting

Lung CancerPhase 1/Phase 2

Active, not recruiting

Hairy Cell LeukemiaPhase 2

Active, not recruiting

LeukemiaApproved

Approved

Metastatic MelanomaPhase 3

Active, not recruiting

Cardiac HypertrophyApproved

Approved

Uveal MelanomaPhase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 1

Active, not recruiting

Showing 10 of 32 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Mektovi

Tecentriq

Gemzar

GGynecologic Oncology Group

Blenoxane

Bristol-Myers Squibb

Spravato

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Acupan

YYonsei University

Aquasol E

NNational Eye Institute (NEI)

Paracetamol

Systemic Therapy

Bristol-Myers Squibb

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Treatment

NCT05554367

Phase 3Active, not recruiting

Metastatic Melanoma

NCT04657991

Q4 2026

Phase 2Active, not recruiting

Advanced Biliary Tract Carcinoma

NCT05564403

Phase 1Active, not recruiting

Melanoma

NCT03543969

Phase 1Active, not recruiting

Non-Small Cell Carcinoma

NCT03991819

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT05195632

Clinical

Trials by Indication[1]

Melanoma14 trials

Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT04741997·50 enrolled

Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma

Terminated·JJason J. Luke, MD·Phase 1/2·NCT04655157·2 enrolled

Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02910700·52 enrolled

Show 11 more trials

Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT03543969·14 enrolled

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

Recruiting·PPierre Fabre Pharma GmbH··NCT04045691·750 enrolled

Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma

Terminated· Pfizer logo

Pfizer·Phase 1·NCT03878719·1 enrolled

Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain

Completed·GGrupo Español Multidisciplinar de Melanoma·Phase 2·NCT03898908·48 enrolled

Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma

Terminated·JJonsson Comprehensive Cancer Center·Phase 2·NCT04375527·3 enrolled

A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT04511013·112 enrolled

Binimetinib and Imatinib for Unresectable Stage III-IV KIT-Mutant Melanoma

Recruiting·UUniversity of California, San Francisco·Phase 2·NCT04598009·25 enrolled

Melanoma Metastasized to the Brain and Steroids

Recruiting·IInge Marie Svane·Phase 2·NCT03563729·80 enrolled

Encorafenib + Binimetinib + Pembrolizumab in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

Completed·PProf. Dr. med. Dirk Schadendorf·Phase 1/2·NCT02902042·16 enrolled

A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma

Terminated· Pfizer logo

Pfizer·Phase 2·NCT05926960·38 enrolled

A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS

Recruiting· Pfizer logo

Pfizer·Phase 1·NCT05355701·267 enrolled

Metastatic Melanoma7 trials

Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05026983·35 enrolled

Overcoming Primary Resistance to Immunotherapy in Metastatic Melanoma

Completed·—·Phase 2·NCT05304546·1 enrolled

Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations

Withdrawn·JJonsson Comprehensive Cancer Center·Phase 2·NCT02263898

Show 4 more trials

Encorafenib, Binimetinib and Palbociclib in BRAF-mutant Metastatic Melanoma CELEBRATE

Unknown status·PPeter MacCallum Cancer Centre, Australia·Phase 1/2·NCT04720768·78 enrolled

A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT04657991·257 enrolled

Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US

Completed· Pfizer logo

Pfizer··NCT05260684·716 enrolled

Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

Recruiting·RRina Plattner·Phase 1·NCT04903119·30 enrolled

Non-Small Cell Lung Cancer7 trials

Binimetinib and Hydroxychloroquine in Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer

Completed·—·Phase 2·NCT04735068·9 enrolled

Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)

Terminated· Pfizer logo

Pfizer·Phase 1/2·NCT04585815·34 enrolled

An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer

Completed· Pfizer logo

Pfizer·Phase 2·NCT03915951·98 enrolled

Show 4 more trials

Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer

Terminated·UUniversity of California, San Francisco·Phase 1·NCT04005144·3 enrolled

Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer

Completed·—·Phase 1·NCT03170206·34 enrolled

Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer

Active, not recruiting·PPierre Fabre Medicament·Phase 2·NCT05195632·63 enrolled

Binimetinib With Docetaxel in Treating Patients With Previously Treated, Stage IV Non-small Cell Lung Cancer

Withdrawn·JJonsson Comprehensive Cancer Center·Phase 1·NCT02451865

Colorectal Cancer5 trials

Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer

Completed·—·Phase 2·NCT03981614·102 enrolled

Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer

Completed·PPierre Fabre Medicament·Phase 2·NCT03693170·95 enrolled

Study of Pembrolizumab, Binimetinib, and Bevacizumab in Patients With Refractory Colorectal Cancer

Completed·UUniversity of Colorado, Denver·Phase 2·NCT03475004·53 enrolled

Show 2 more trials

MEK and MET Inhibition in Colorectal Cancer

Completed·UUniversity of Oxford·Phase 1·NCT02510001·82 enrolled

Neoadjuvant Encorafenib, Binimetinib and Cetuximab for Patients With BRAF V600E Mutated/pMMR Localized Colorectal Cancer

Completed·AAIO-Studien-gGmbH·Phase 2·NCT05510895·2 enrolled

Breast Cancer5 trials

Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer

Recruiting·LLaura Huppert, MD, BA·Phase 2·NCT03971409·150 enrolled

Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer

Completed·MMayo Clinic·Phase 1/2·NCT03106415·23 enrolled

Testing the Combination of the Anticancer Drugs ZEN003694 and Binimetinib in Patients With Advanced/Metastatic or Unresectable Solid Tumors With RAS Alterations and Triple Negative Breast Cancer

Suspended·NNational Cancer Institute (NCI)·Phase 1·NCT05111561·42 enrolled

Show 2 more trials

Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT05554354·1 enrolled

TROPION-Breast02: Dato-DXd in mTNBC

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04892017·900 enrolled

32 more indications

Pancreatic Cancer4 trials

Binimetinib and Hydroxychloroquine in Treating Patients With KRAS Mutant Metastatic Pancreatic Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04132505·39 enrolled

Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)

Recruiting·NNational Cancer Center, Japan·Phase 2·NCT06159478·32 enrolled

Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation

Terminated·—·Phase 2·NCT04390243·6 enrolled

Show 1 more trial

Binimetinib and Palbociclib Before Surgery for the Treatment of Operable KRAS-Positive Lung, Colorectal, or Pancreatic Cancer

Withdrawn·RRoswell Park Cancer Institute·Phase 1·NCT04870034

Metastatic Colorectal Cancer4 trials

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

Completed· Pfizer logo

Pfizer·Phase 3·NCT02928224·702 enrolled

Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer

Terminated·UUniversity of California, San Francisco·Phase 1·NCT04044430·2 enrolled

Study of Binimetinib + Nivolumab Plus or Minus Ipilimumab in Patients With Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer With RAS Mutation

Completed· Pfizer logo

Pfizer·Phase 2·NCT03271047·75 enrolled

Show 1 more trial

Safety and Efficacy of Pembrolizumab (MK-3475) Plus Binimetinib Alone or Pembrolizumab Plus Chemotherapy With or Without Binimetinib in Metastatic Colorectal Cancer (mCRC) Participants (MK-3475-651/KEYNOTE-651)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT03374254·116 enrolled

Advanced Solid Tumors3 trials

PF-07284892 in Participants With Advanced Solid Tumors

Terminated· Pfizer logo

Pfizer·Phase 1·NCT04800822·53 enrolled

Binimetinib and Encorafenib for the Treatment of Advanced Solid Tumors With Non-V600E BRAF Mutations

Active, not recruiting·UUniversity Health Network, Toronto·Phase 2·NCT03839342·26 enrolled

Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT03864042·56 enrolled

Metastasis2 trials

An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

Terminated· Pfizer logo

Pfizer·Phase 2·NCT03911869·13 enrolled

Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis

Active, not recruiting·UUNICANCER·Phase 2·NCT04074096·10 enrolled

Treatment2 trials

Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05554367·199 enrolled

Testing Binimetinib as a Potential Targeted Treatment in Cancers With NRAS Genetic Changes (MATCH-Subprotocol Z1A)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04439344·53 enrolled

Clinical Trial1 trial

The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials

Recruiting· Pfizer logo

Pfizer·Phase 4·NCT05203172·46 enrolled

Uveal Melanoma1 trial

Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT05170334·7 enrolled

Chemotherapy1 trial

Binimetinib in Addition to Standard Chemotherapy in KRAS Mutated NSCLC.

Completed·SSwiss Cancer Institute·Phase 1·NCT02964689·18 enrolled

Advanced1 trial

A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT03843775·17 enrolled

Biliary Cancer1 trial

Personalized Medicine for Advanced Biliary Cancer Patients

Recruiting·UUNICANCER·Phase 3·NCT05615818·800 enrolled

Recurrent1 trial

Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03973918·5 enrolled

Gastrointestinal Stromal Tumor1 trial

Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST)

Withdrawn·DDeciphera Pharmaceuticals, LLC·Phase 1/2·NCT05080621

Locally Advanced1 trial

A Study of Avelumab, Binimetinib and Talazoparib in Patients With Locally Advanced or Metastatic RAS-mutant Solid Tumors

Terminated· Pfizer logo

Pfizer·Phase 1/2·NCT03637491·36 enrolled

Thyroid Cancer1 trial

Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer

Active, not recruiting·PProvidence Health & Services·Phase 2·NCT04061980·24 enrolled

Hairy Cell Leukemia1 trial

Binimetinib for People With Relapsed/Refractory BRAF Wild Type Hairy Cell Leukemia and Variant

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04322383·40 enrolled

Patients With Solid Tumors1 trial

Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions

Recruiting·IIDEAYA Biosciences·Phase 1/2·NCT03947385·336 enrolled

Lung Cancer1 trial

Lorlatinib Combinations in Lung Cancer

Unknown status·MMassachusetts General Hospital·Phase 1/2·NCT04292119·96 enrolled

Patients With Advanced Solid Tumors1 trial

JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors

Completed·AAllist Pharmaceuticals, Inc.·Phase 1/2·NCT04720976·58 enrolled

Pilot Study1 trial

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Terminated·PPeter MacCallum Cancer Centre, Australia·N/A·NCT04801966·3 enrolled

Relapsed/Refractory1 trial

Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04324112·45 enrolled

Plexiform Neurofibroma1 trial

Phase II Study of Binimetinib in Children and Adults With NF1 Plexiform Neurofibromas

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT03231306·45 enrolled

Adamantinomatous Craniopharyngioma1 trial

MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

Recruiting·NNationwide Children's Hospital·Phase 2·NCT05286788·38 enrolled

NSCLC1 trial

ENCOrafenib With Binimetinib in bRAF NSCLC

Active, not recruiting·IIntergroupe Francophone de Cancerologie Thoracique·Phase 2·NCT04526782·119 enrolled

Multiple Myeloma1 trial

BRAF/MEK Inhibition in Relapsed/Refractory Multiple Myeloma (BIRMA)

Completed·UUniversity of Heidelberg Medical Center·Phase 2·NCT02834364·12 enrolled

Squamous Carcinoma1 trial

A Phase I/Ib Study of MEK162, a MEK Inhibitor, in Combination With Carboplatin and Pemetrexed in Patients With Non-squamous Carcinoma of the Lung

Completed·UUniversity Health Network, Toronto·Phase 1·NCT02185690·13 enrolled

Solid Tumors1 trial

A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement

Terminated· Pfizer logo

Pfizer·Phase 1·NCT04543188·65 enrolled

Advanced Lymphoma1 trial

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

Advanced Malignant Solid Neoplasm1 trial

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05564377·2,900 enrolled

Melanoma of Unknown Primary1 trial

A Phase II Neoadjuvant Study of Encorafenib With Binimetinib in Patients With Resectable Locoregional Metastases From Cutaneous or Unknown Primary Melanoma (Stages III N1B/C/D)

Terminated·EECOG-ACRIN Cancer Research Group·Phase 2·NCT04221438·3 enrolled

Advanced Biliary Tract Carcinoma1 trial

FOLFOX in Combination With Binimetinib as 2nd Line Therapy for Patients With Advanced Biliary Tract Cancers With MAPK Pathway Alterations: A ComboMATCH Treatment Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05564403·66 enrolled

Non-small Cell Carcinoma1 trial

Phase I/Ib Study of Binimetinib, a MEK Inhibitor, in Combination With Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Active, not recruiting·UUniversity Health Network, Toronto·Phase 1·NCT03991819·40 enrolled

Unspecified2 trials

Relative Bioavailability of Binimetinib 3 x 15 mg and 45 mg Formulations

Unknown status·PPierre Fabre Medicament·Phase 1·NCT05103891·14 enrolled

Bioequivalence Binimetinib 3 x 15 mg and 45 mg Formulations

Completed·PPierre Fabre Medicament·Phase 1·NCT05810740·37 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 27, 2018

MEKTOVI

NDA NDA210498

Sources

References

[1]
ClinicalTrials.gov — 81 trial records for Binimetinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Mektovi drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Binimetinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Binimetinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210498). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Mektovi. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: MEK Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Patent Landscape[6]

Patent Cliff

Aug 27, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7777050Mar 13, 2026

10005761Aug 27, 2030

9850229Aug 27, 2030

9314464Jul 4, 2031

9980944Oct 18, 2033

2 more patents

9598376Oct 18, 2033

9562016Oct 18, 2033

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