Regulatory approval

Published by the Health Canada. Approved

Health Canada approved dabrafenib mesylate in combination with trametinib 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.

This is written in the approval document as:

TAFINLAR (dabrafenib mesylate) in combination with trametinib 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.

Citation

Novartis Pharmaceuticals Canada Inc. Tafinlar (dabrafenib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00083523.PDF. Revised February 2026. Accessed April 2026.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	BRAF p.V600E	Low-Grade Glioma	Dabrafenib, Trametinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals