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.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) BRAF p.V600E Melanoma Binimetinib, Encorafenib