Braftovi (encorafenib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Pierre Fabre Medicament. Braftovi (encorafenib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf. Revised July 2026. Accessed August 2, 2026.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
Encorafenib is indicated in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. 2
Encorafenib is indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy. 1
Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation. 1
Encorafenib in combination with cetuximab and FOLFOX is indicated for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation. 1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations Biomarkers Cancer types Therapies
EMA (1) BRAF p.V600E Melanoma Binimetinib, Encorafenib
EMA (1) BRAF p.V600K Melanoma Binimetinib, Encorafenib
EMA (1) BRAF p.V600E Non-Small Cell Lung Cancer Binimetinib, Encorafenib
EMA (1) BRAF p.V600E Colorectal Adenocarcinoma Cetuximab, Encorafenib
EMA (1) BRAF p.V600E Colorectal Adenocarcinoma Cetuximab, Encorafenib, Fluorouracil, Oxaliplatin