Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized encorafenib in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 variant. The efficacy and safety of encorafenib have been established only in patients with melanoma tumours expressing BRAF V600E and V600K variants or colorectal tumours expressing BRAF V600E.

This is written in the approval document as:

Encorafenib is indicated in combination with binimetinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	BRAF p.V600E	Melanoma	Binimetinib, Encorafenib
EMA (1)	BRAF p.V600K	Melanoma	Binimetinib, Encorafenib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2018-09-19	European Medicines Agency	Indication received approval from the European Commission.