Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BRAF p.V600K status confers therapeutic sensitivity to Dabrafenib, Trametinib in patients with Non-Small Cell Lung Cancer.

The European Medicines Agency (EMA) has authorized dabrafenib in combination with trametinib for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 variant.

This statement is based on a regulatory approval from the European Medicines Agency:

Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non-small cell lung cancer 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.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2017-03-29	European Medicines Agency	Indication received approval from the European Commission.