Regulatory approval

Published by the Health Canada.

Health Canada approved dabrafenib mesylate, in combination with trametinib for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of lymph node(s), following complete resection.

This is written in the approval document as:

TAFINLAR (dabrafenib mesylate), in combination with trametinib, is indicated for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of lymph node(s), following complete resection.

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.

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Therapeutic response

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

Type Biomarker(s) Cancer type Therapy(ies)