Regulatory approval

Published by the Health Canada.

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/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)
Sensitivity (+) BRAF p.V600E Low-Grade Glioma, NOS Dabrafenib, Trametinib