Regulatory approval

Published by the Health Canada.

Health Canada approved encorafenib in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation.

This is written in the approval document as:

BRAFTOVI (encorafenib) is indicated, in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a validated test.

Citation

Pfizer Canada ULC. Braftovi (encorafenib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00081199.PDF. Revised July 2025. Accessed April 2026.

Therapeutic response

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

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HC (1) BRAF p.V600E Colorectal Adenocarcinoma Cetuximab, Encorafenib, Fluorouracil, Oxaliplatin