Mekinist (trametinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	3
MEKINIST (trametinib), in combination with dabrafenib, is indicated for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of lymph nodes, following complete resection.
MEKINIST (trametinib) in combination with dabrafenib is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.	1
MEKINIST (trametinib) in combination with dabrafenib is indicated for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.	1
MEKINIST (trametinib) in combination with dabrafenib is indicated for the treatment of pediatric patients 1 year of age and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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