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.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) BRAF p.V600K Melanoma Trametinib
Sensitivity (+) BRAF p.V600E Melanoma Trametinib
Sensitivity (+) BRAF p.V600E High-Grade Glioma, NOS Dabrafenib, Trametinib