Regulatory approval

Published by the European Medicines Agency. Superseded

The European Medicines Agency (EMA) has authorized dabrafenib as a monotherapy or in combination with trametinib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 variant.

This is written in the approval document as:

Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

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

Contributions

Date	Contributor	Description
2015-08-25	European Medicines Agency	Indication received approval from the European Commission.