Regulatory approval

Published by the Health Canada.

Health Canada approved encorafenib in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.

This is written in the approval document as:

BRAFTOVI (encorafenib) is indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.

Citation

Pfizer Canada ULC. Braftovi (encorafenib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00074711.PDF. Revised February 2024. Accessed June 2025.

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 Melanoma Binimetinib, Encorafenib