Last reviewed 2026-04-20 · How we verify

Braftovi (encorafenib)

Braftovi works by blocking the activity of a specific protein called BRAF that is involved in cancer cell growth.

Braftovi (encorafenib) is a small molecule developed by Array Biopharma Inc that targets the RAF proto-oncogene serine/threonine-protein kinase. It is FDA-approved for treating BRAF mutation-positive colorectal cancer, metastatic malignant melanoma, and unresectable malignant melanoma with BRAF gene mutation. Braftovi is a patented medication with no generic manufacturers available. Key safety considerations include its short half-life of 3.5 hours. It is a commercially available medication.

At a glance

Mechanism of action

Encorafenib is kinase inhibitor that targets BRAF V600E, as well as wild-type BRAF and CRAF in in vitro cell-free assays with IC50 values of 0.35, 0.47, and 0.3 nM, respectively. Mutations in the BRAF gene, such as BRAF V600E, can result in constitutively activated BRAF kinases that may stimulate tumor cell growth. Encorafenib was also able to bind to other kinases in vitro including JNK1, JNK2, JNK3, LIMK1, LIMK2, MEK4, and STK36 and reduce ligand binding to these kinases at clinically achievable concentrations (<=0.9 uM).Encorafenib inhibited in vitro growth of tumor cell lines expressing BRAF V600 E, D, and mutations. In mice implanted with tumor cells expressing BRAF V600E, encorafenib induced tumor regressions associated with RAF/MEK/ERK pathway suppression.Encorafenib and binimetinib target two different kinases in the RAS/RAF/MEK/ERK pathway. Compared with either drug alone, coadministration of encorafenib and binimetinib resulted in greater anti-prolif

Approved indications

• BRAF mutation-positive colorectal cancer
• Metastatic malignant melanoma
• Unresectable malignant melanoma with BRAF gene mutation

Common side effects

• Fatigue
• Pyrexia
• Nausea
• Vomiting
• Abdominal pain
• Arthralgia
• Hyperkeratosis
• Rash
• Constipation
• Headache
• Dizziness
• Peripheral neuropathy

Key clinical trials

• Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation (PHASE2)
• Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer (PHASE1)
• A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies (PHASE1,PHASE2)
• Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasis (PHASE2)
• An Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600-mutant Non-small Cell Lung Cancer (PHASE2)
• A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer (PHASE2)
• The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials (PHASE4)
• 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 (PHASE1)

Patents

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Braftovi CI brief — competitive landscape report
• Braftovi updates RSS · CI watch RSS
• Pfizer portfolio CI