Regulatory approval

Published by the Health Canada.

Health Canada approved dabrafenib as a monotherapy, or in combination with trametinib, for the treatment of patients with the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

This is written in the approval document as:

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.

Citation

Novartis Pharmaceuticals Canada Inc. Tafinlar (dabrafenib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00077956.PDF. Revised December 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 Dabrafenib
HC (1) BRAF p.V600K Melanoma Dabrafenib