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Braftovi

(Encorafenib)

ApprovedSmall molecule

Encorafenib is used to treat certain types of cancer, particularly melanoma and colorectal cancer that have a specific genetic mutation called BRAF V600E. It works by blocking a protein that helps cancer cells grow.[2] Braftovi is currently approved and in use across 17 indications[4].[1]

Braftovi is one of 392 small molecule programs targeting Metastasis. It is currently in Approved.

17

Indications

71

Total Trials

37

Active Trials

391

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

10

Patents

Pipeline

Status by Indication[4][1]

Indication

MetastasisActive, not recruiting

Colon AdenocarcinomaActive, not recruiting

Cutaneous MelanomaActive, not recruiting

Hairy Cell LeukemiaApproved

Metastatic MelanomaActive, not recruiting

Colorectal NeoplasmActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Rectum CancerActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Colorectal CancerActive, not recruiting

MetastasisPhase 2

Active, not recruiting

Colon AdenocarcinomaPreclinical

Active, not recruiting

Cutaneous MelanomaPhase 1/Phase 2

Active, not recruiting

Hairy Cell LeukemiaApproved

Approved

Metastatic MelanomaPhase 3

Active, not recruiting

Colorectal NeoplasmApproved

Active, not recruiting

Metastatic Colorectal CancerPhase 3

Active, not recruiting

Rectum CancerPhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

Colorectal CancerPhase 2

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Braftovi

PORTRAZZA

Imjudo

Vizimpro

Gilotrif

Boehringer Ingelheim

Ofev

Boehringer Ingelheim

Immunotherapy

Bristol-Myers Squibb

Remeron

OOrganon and Co

PD-1 Inhibitor

Johnson & Johnson

Tyrosine Kinase Inhibitor

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

Timeline

Expected Milestones

Q3 2026

Phase 3Active, not recruiting

Metastatic Melanoma

NCT04657991

Q4 2026

Phase 1Active, not recruiting

Melanoma

NCT03543969

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT05195632

Q1 2027

Phase 2Active, not recruiting

Targeted Therapy

NCT03235245

Treatment

NCT04673955

Phase 2Active, not recruiting

Metastatic Colorectal Cancer

NCT05217446

Clinical

Trials by Indication[1]

Melanoma18 trials

Perioperative Encobini in BRAFV600 Mutant Stage III (B/C/D) or Oligometastatic Stage IV Melanoma

Unknown status·CCCTU- Cancer Theme·Phase 2·NCT05097378·45 enrolled

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

Active, not recruiting·PPierre Fabre Medicament·Phase 3·NCT05270044·815 enrolled

Surgical or Radiotherapeutic Intervention Concerning Large Singular Stable to Progressive Metastases in Patients With BRAFV600-mutated Melanoma Receiving Treatment With Encorafenib + Binimetinib

Not yet recruiting·SSRH Wald-Klinikum Gera GmbH·Phase 4·NCT07092410·101 enrolled

Show 15 more trials

Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma

Withdrawn·PPierre Fabre Medicament·Phase 1·NCT04759846

Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases

Recruiting·GGrupo Español Multidisciplinar de Melanoma·Phase 2·NCT06887088·33 enrolled

(Neo)Adjuvant BRAF/MEK Inhibition in pN1c Melanoma

Unknown status·LLeiden University Medical Center·Phase 2·NCT05767879·28 enrolled

UK ENcorafenib and BInimetinib Real-world Study in Melanoma

Recruiting·PPierre Fabre Ltd··NCT07022457·50 enrolled

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

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

Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment

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

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

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

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

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

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

Metastatic Colorectal Cancer11 trials

Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer

Recruiting·OOslo University Hospital·Phase 2·NCT05725200·40 enrolled

Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.

Recruiting·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·Phase 2·NCT06640166·25 enrolled

A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer

Active, not recruiting· Pfizer logo

Pfizer·Phase 2·NCT05217446·107 enrolled

Show 8 more trials

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT04607421·831 enrolled

Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT04017650·38 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 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

Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT05985954·27 enrolled

ZN-c3 in Adult Participants With Metastatic Colorectal Cancer

Terminated·KK-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.·Phase 1·NCT05743036·44 enrolled

A Study Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer.

Completed·PPierre Fabre Medicament·Phase 2·NCT05004350·107 enrolled

ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07318389·100 enrolled

Metastatic Melanoma6 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

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

Show 3 more trials

Overcoming Primary Resistance to Immunotherapy in Metastatic Melanoma

Completed·—·Phase 2·NCT05304546·1 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

Advanced Solid Tumors4 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

Show 1 more trial

CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)

Unknown status·CCuregenix Inc.·Phase 1·NCT02675946·72 enrolled

Non-Small Cell Lung Cancer3 trials

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

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

27 more indications

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

Rectum Cancer1 trial

Encorafenib Plus Cetuximab in a Neoadjuvant Setting in Patients With BRAF Mutation Localised Colon or Upper Rectum Cancer

Recruiting·FFederation Francophone de Cancerologie Digestive·Phase 2·NCT05706779·30 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

Stage III Colon Cancer1 trial

Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

Recruiting·MMassachusetts General Hospital·Phase 3·NCT03803553·400 enrolled

Targeted Therapy1 trial

Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib

Active, not recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT03235245·271 enrolled

Colorectal Cancer1 trial

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

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

Advanced/Metastatic Cancer1 trial

A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02857270·210 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

Solid Tumors1 trial

Phase 1 Safety Study of Encorafenib in Chinese Patients With Advanced Metastatic BRAF V600E Mutant Solid Tumors

Completed·PPierre Fabre Medicament·Phase 1·NCT05003622·3 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

BRAF V600E1 trial

Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC

Active, not recruiting·GGruppo Oncologico del Nord-Ovest·Phase 2·NCT06578559·16 enrolled

Pancreatic Cancer1 trial

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

Terminated·—·Phase 2·NCT04390243·6 enrolled

NSCLC1 trial

ENCOrafenib With Binimetinib in bRAF NSCLC

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

Gastrointestinal1 trial

A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies

Completed·EErasca, Inc.·Phase 1/2·NCT05039177·101 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

Multiple Myeloma1 trial

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

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

Biliary Cancer1 trial

Personalized Medicine for Advanced Biliary Cancer Patients

Recruiting·UUNICANCER·Phase 3·NCT05615818·800 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

Treatment1 trial

BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment

Recruiting·PPierre Fabre Pharma GmbH··NCT04673955·500 enrolled

Cutaneous Melanoma1 trial

Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma

Recruiting·UUniversity of Utah·Phase 1/2·NCT06194929·33 enrolled

Combination Therapy1 trial

Combination Therapy for BRAF-V600E Metastatic CRCm

Recruiting·VVall d'Hebron Institute of Oncology·Phase 2·NCT06411600·94 enrolled

Metastatic Colon Adenocarcinoma1 trial

Randomized Phase II Trial of Encorafenib and Cetuximab With or Without Nivolumab (NSC #748726) for Patients With Previously Treated, Microsatellite Stable, BRAFV600E Metastatic and/or Unresectable Colorectal Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05308446·86 enrolled

Metastatic Colorectal Adenocarcinoma1 trial

A Phase 1 Study of ZEN003694 (ZEN-3694) in Combination With Cetuximab and Encorafenib in Patients With Refractory BRAF V600E Metastatic Colorectal Cancer

Suspended·NNational Cancer Institute (NCI)·Phase 1·NCT06102902·30 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

Colon Adenocarcinoma1 trial

Randomized Trial of Consolidation Targeted Adjuvant Therapy With Encorafenib and Cetuximab Versus Usual Care for Patients With Stage II/III BRAF V600E Colon Cancer

Active, not recruiting·AAlliance for Clinical Trials in Oncology·Preclinical·NCT05710406·1 enrolled

Unspecified2 trials

StrataPATH™ (Precision Indications for Approved Therapies)

Terminated·SStrata Oncology·Phase 2·NCT05097599·11 enrolled

A Relative Bioavailability Study Evaluating Two New Encorafenib Formulations

Completed· Pfizer logo

Pfizer·Phase 1·NCT05446142·18 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 27, 2018

BRAFTOVI

NDA NDA210496

Sources

References

[1]
ClinicalTrials.gov — 71 trial records for Encorafenib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Braftovi drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Encorafenib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Encorafenib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA210496). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Braftovi. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Encorafenib. U.S. National Library of Medicine.
[8]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

Patent Landscape[6]

Patent Cliff

Jul 23, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8946250Jul 23, 2029

8541575Feb 26, 2030

RE49556Feb 27, 2030

9593099Aug 27, 2030

9850230Aug 27, 2030

5 more patents

9593100Aug 27, 2030

10258622Nov 21, 2032

9387208Nov 21, 2032

9763941Nov 21, 2032

9474754Aug 5, 2033

Key Publications[7]

Encorafenib Plus Cetuximab in BRAF V600E CRC: BEACON Final

N Engl J MedJul 28, 2022DOI: 10.1056/NEJMoa2205852

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