Regulatory approval

Published by the European Medicines Agency. Approved

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

This is written in the approval document.

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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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