Regulatory approval

Published by the Food and Drug Administration. Approved

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.

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.

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Therapeutic response

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

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

Contributions

Date Contributor Description
2026-02-24 Food and Drug Administration Indication received traditional approval.
2025-01-10 Van Allen lab Additional FDA approvals for initial version
2024-12-20 Food and Drug Administration Indication received traditional approval.