Braftovi (encorafenib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Array BioPharma, Inc. Braftovi (encorafenib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210496s006lbl.pdf. Revised April 2020. Accessed October 6, 2026.

Regulatory approvals

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

Indication	Statements
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	BRAF p.V600E	Colorectal Adenocarcinoma	Cetuximab, Encorafenib