Regulatory approval

Published by the European Medicines Agency. Superseded

The European Medicines Agency (EMA) has authorized dabrafenib in combination with trametinib for the adjuvant treatment of adult patients with stage 3 melanoma with a BRAF V600 variant, following complete resection.

This is written in the approval document as:

Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.

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
2018-08-27	European Medicines Agency	Indication received approval from the European Commission.