TheraRadar
Data updated: May 26, 2026

BRAFTOVI (encorafenib)

Trial Activity: Stable 22 active trials
Orphan Drug
Oncology Approved 2018-06-27
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Pfizer conducting 11 trials (24%)
114 indications explored (Broad Platform)
→ metastatic melanoma (8 trials)
→ metastatic colorectal cancer (7 trials)
→ melanoma (5 trials)
9
Indications
--
Phase 3 Trials
2
Priority Reviews
7
Years on Market

Details

Status
Discontinued
First Approved
2018-06-27
Patent Cliff
2033

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Routes
ORAL
Dosage Forms
CAPSULE

Companies

ARRAY BIOPHARMA INC
Active Ingredient: ENCORAFENIB

BRAFTOVI Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2018 to 2026 · 8 indication expansions
Feb 2026 SUPPL
Efficacy
FDA Letter Label
Mar 2025 SUPPL
Efficacy
FDA Letter Label
Dec 2024 SUPPL Priority
Efficacy
FDA Letter Label

What BRAFTOVI Treats

9 FDA approvals

Originally approved for its first indication in 2018 . Covers 9 distinct patient populations.

  • Other (9)
📋

Clinical Trial Registry

46 trials
Trial Sponsor ID Phase Status Title
NCT06102902 NCI-2023-08787 NCI-2023-08787, 2024-0120 Ph 1 suspended Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer
NCT04221438 results posted EA6183 NCI-2019-07407, EA6183 Ph 2 terminated Testing Treatment With Encorafenib and Binimetinib Before Surgery for Melanoma With Lymph Node Involvement
NCT05195632 OCEANII W00090GE203 CTR20212962, CTR20212961 Ph 2 active not recruiting Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer
NCT05004350 NAUTICALCRC results posted W00090GE202 Ph 2 completed 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.
NCT05308446 NCI-2022-02494 NCI-2022-02494, S2107 Ph 2 active not recruiting Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation
NCT05026983 2021-0205 NCI-2021-08716, 2021-0205 Ph 2 recruiting Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases
NCT04061980 2020000039 IST-818-210X, CA209-73R Ph 2 active not recruiting Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer
NCT05217446 SEAMARK C4221022 SEAMARK, 2024-512119-34-00 Ph 2 active not recruiting A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
NCT04657991 C4221016 KEYNOTE-B80; STARBOARD, 2024-512038-13-00 Ph 3 active not recruiting A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
NCT04324112 200076 20-C-0076 Ph 2 recruiting Encorafenib Plus Binimetinib for People With BRAF V600 Mutated Relapsed/Refractory HCL
NCT05039177 HERKULES-3 ERAS-007-03 Ph 1, Ph 2 completed A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies
NCT03915951 results posted ARRAY-818-202 C4221008; PHAROS, 2024-515929-28-00 Ph 2 completed An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer
NCT05985954 2023-0254 NCI-2023-06254 Ph 1 recruiting 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
NCT05926960 PORTSIDE C4221023 KEYNOTE PNC92; PORTSIDE, 2023-509471-17-00 Ph 2 terminated A Study Comparing 3 Study Medicines (Encorafenib, Binimetinib, Pembrolizumab) to 2 Study Medicines (Ipilimumab and Nivolumab) in Patients With Advanced Melanoma
NCT04903119 MCC-20-MEL-11-PMC 1R01CA258751-01A1 Ph 1 recruiting Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma
NCT05710406 A022004 NCI-2022-09129 Ph 2, Ph 3 active not recruiting Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer
NCT04585815 results posted B8011011 2020-002829-28 Ph 1, Ph 2 terminated Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study)
NCT06578559 BRICKET BRICKET Ph 2 active not recruiting Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC
NCT02910700 2015-0605 NCI-2016-01940, 2015-0605 Ph 2 active not recruiting Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma
NCT06194929 DETERMINE HCI168254 Ph 1, Ph 2 recruiting Defactinib and Avutometinib, With or Without Encorafenib, for the Treatment of Patients With Brain Metastases From Cutaneous Melanoma
NCT04017650 2018-0993 NCI-2019-04169, 2018-0993 Ph 1, Ph 2 active not recruiting Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer
NCT04511013 S2000 NCI-2020-05496, S2000 Ph 2 recruiting A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
NCT04607421 C4221015 2023-509405-77-00, BREAKWATER Ph 3 active not recruiting A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
NCT05743036 ZN-c3-016 Z0011001 Ph 1 terminated ZN-c3 in Adult Participants With Metastatic Colorectal Cancer
NCT05304546 MK3475-C01 9222-22-SMC Ph 2 completed Overcoming Primary Resistance to Immunotherapy in Metastatic Melanoma
NCT03898908 EBRAIN-MEL results posted GEM-1802 2018-002530-20 Ph 2 completed Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain
NCT05615818 SAFIR-ABC10 UC-GMP-2201 - PRODIGE 78 2022-000190-19, 2022-502403-30-00 Ph 3 recruiting Personalized Medicine for Advanced Biliary Cancer Patients
NCT03839342 BEAVER BEAVER-001 / IST-818-207X Ph 2 active not recruiting Binimetinib and Encorafenib for the Treatment of Advanced Solid Tumors With Non-V600E BRAF Mutations
NCT06411600 BRAVE VHIO23001 Ph 2 recruiting Combination Therapy for BRAF-V600E Metastatic CRCm
NCT03973918 BRAF results posted ABTC 1802 UM1CA137443 Ph 2 terminated Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG
NCT04800822 C4481001 2022-502431-18-00, 2022-003166-21 Ph 1 terminated PF-07284892 in Participants With Advanced Solid Tumors
NCT03843775 results posted 18-547 Ph 1, Ph 2 completed A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers
NCT03864042 results posted ARRAY-818-103 C4221003, 2019-001036-66 Ph 1 completed Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors
NCT05003622 OCEANI results posted W00090GE102 Ph 1 completed Phase 1 Safety Study of Encorafenib in Chinese Patients With Advanced Metastatic BRAF V600E Mutant Solid Tumors
NCT04655157 QUAD01 results posted HCC 20-190 CA209-7Y4 Ph 1, Ph 2 terminated 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
NCT04390243 results posted ACCRU-GI-1907 NCI-2020-02972, ACCRU-GI- 1907 Ph 2 terminated Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation
NCT03693170 ANCHOR-CRC results posted W00090 GE 2 01 Ph 2 completed Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer
NCT02928224 BEACON CRC results posted ARRAY-818-302 BEACON CRC, 2015-005805-35 Ph 3 completed 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
NCT02834364 GMMG-BIRMA CLGX818ADE01T 2014-004597-42 Ph 2 completed BRAF/MEK Inhibition in Relapsed/Refractory Multiple Myeloma (BIRMA)
NCT03563729 MEMBRAINS MM1807 Ph 2 recruiting Melanoma Metastasized to the Brain and Steroids
NCT03911869 POLARIS results posted ARRAY-818-201 C4221006, 2018-004555-21 Ph 2 terminated 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
NCT03878719 ARRAY-162-115 C4221011, 2018-001946-32 Ph 1 terminated Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma
NCT05725200 EVIDENT EVIDENT Ph 2 recruiting Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer
NCT04044430 19457 NCI-2019-04601 Ph 1 terminated Encorafenib, Binimetinib, and Nivolumab in Treating Microsatellite Stable BRAF V600E Metastatic Colorectal Cancer
NCT02857270 16419 I8S-MC-JUAB, 2016-001907-21 Ph 1 completed A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer
NCT02902042 IMMU-TARGET IST-818-201X Ph 1, Ph 2 completed Encorafenib + Binimetinib + Pembrolizumab in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BRAFTOVI FDA Label Details

View full patent landscape →
13 OB patents · 4 families · 275 international docs across 54 countries

BRAFTOVI Patents & Exclusivity

Latest Patent: Aug 2033
Exclusivity: Oct 2030

Patents (13 active)

US9474754 Expires Aug 5, 2033
US9763941 Expires Nov 21, 2032
US10258622 Expires Nov 21, 2032
US9387208 Expires Nov 21, 2032
US9314464 Expires Jul 4, 2031
US10005761 Expires Aug 27, 2030
US9850230 Expires Aug 27, 2030
US9850229 Expires Aug 27, 2030
US9593099 Expires Aug 27, 2030
US9593100 Expires Aug 27, 2030
USRE49556 Expires Feb 27, 2030
US8541575 Expires Feb 26, 2030
US8946250 Expires Jul 23, 2029

Exclusivity

I-928 Until Oct 2026
I-957 Until Dec 2027
ODE-445 Until Oct 2030
I-928 Until Oct 2026
I-957 Until Dec 2027
ODE-445 Until Oct 2030
I-928 Until Oct 2026
I-957 Until Dec 2027
ODE-445 Until Oct 2030
I-928 Until Oct 2026
I-957 Until Dec 2027
ODE-445 Until Oct 2030
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2033
  • • 94 active patents

Trial Analysis

  • • 46 total trials
  • • Stage: Stable

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA210496 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment