Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized encorafenib in combination with cetuximab and FOLFOX (folinic acid, 5-fluorouracil, and oxaliplatin) for the first-line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation.

This is written in the approval document as:

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.

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	Colorectal Adenocarcinoma	Cetuximab, Encorafenib, Fluorouracil, Oxaliplatin

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2026-06-19	European Medicines Agency	Indication received approval from the European Commission.