Regulatory approval

Published by the European Medicines Agency. Approved

Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection.

This is written in the approval document.

Citation

Novartis Europharm Limited. Tafinlar (dabrafenib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf. Revised May 2026. Accessed August 2, 2026.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	BRAF p.V600E	Melanoma	Dabrafenib, Trametinib
EMA (1)	BRAF p.V600K	Melanoma	Dabrafenib, Trametinib

Contributions

Date	Contributor	Description
2026-04-30	European Medicines Agency	Indication received approval from the European Commission.
2024-10-20	Van Allen lab	Adding EMA approvals for use to database