Regulatory approval

Published by the Health Canada. Approved

TAFINLAR (dabrafenib mesylate) is indicated as a monotherapy, or in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

This is written in the approval document.

Citation

Novartis Pharmaceuticals Canada Inc. Tafinlar (dabrafenib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00083523.PDF. Revised February 2026. Accessed April 2026.

View API

Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
HC (1) BRAF p.V600E Melanoma Dabrafenib
HC (1) BRAF p.V600K Melanoma Dabrafenib