Tafinlar (dabrafenib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

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.

Regulatory approvals

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

Indication	Statements
TAFINLAR (dabrafenib mesylate) is indicated as a monotherapy, or in combination with trametinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.	2
TAFINLAR (dabrafenib mesylate), in combination with trametinib, is indicated for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of lymph node(s), following complete resection.
TAFINLAR (dabrafenib mesylate) in combination with trametinib is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.	1
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.	1
TAFINLAR (dabrafenib mesylate) in combination with trametinib 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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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