Regulatory approval

Published by the Health Canada. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
HC (1) BRAF p.V600E Melanoma Binimetinib, Encorafenib