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 adjuvant treatment of adult and adolescent patients aged 12 years and older with stage III melanoma with a BRAF V600 variant, following complete resection.

This is written in the approval document as:

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

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

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