Regulatory approval

Published by the Food and Drug Administration. Approved

BRAFTOVI is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC.

This is written in the approval document.

Citation

Array BioPharma, Inc. Braftovi (encorafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210496s021lbl.pdf. Revised February 2026. Accessed March 2, 2026.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	BRAF p.V600E	Colorectal Adenocarcinoma	Cetuximab, Encorafenib

Contributions

Date	Contributor	Description
2025-01-10	Van Allen lab	Additional FDA approvals for initial version
2020-04-08	Food and Drug Administration	Indication received traditional approval.