Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized trametinib as a monotherapy or in combination with dabrafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 variant. Trametinib's product information further states that trametinib as a monotherapy has not demonstrated clinical activity in patients who have progressed on prior BRAF inhibitor therapy.

This is written in the approval document as:

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

Citation

Novartis Europharm Limited. Mekinist (trametinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/mekinist-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
EMA (1)	BRAF p.V600E	Melanoma	Trametinib
EMA (1)	BRAF p.V600K	Melanoma	Trametinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2015-08-25	European Medicines Agency	Indication received approval from the European Commission.