Regulatory approval

Published by the Health Canada.

Health Canada approved trametinib, as monotherapy or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Clinical data are stronger for BRAF V600E than V600K.

This is written in the approval document as:

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

Citation

Novartis Pharmaceuticals Canada Inc. Mekinist (trametinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00077955.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 Trametinib
HC (1) BRAF p.V600K Melanoma Trametinib
HC (1) BRAF p.V600E High-Grade Glioma, NOS Dabrafenib, Trametinib