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/2024/210496s017lbl.pdf. Revised December 2024. Accessed October 6, 2026.

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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 and fluorouracil-based chemotherapy, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC. 2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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