Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized trametinib in combination with dabrafenib for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refactory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy.

This is written in the approval document as:

Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refactory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy.

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	Differentiated Thyroid Gland Carcinoma	Dabrafenib, Trametinib

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2026-04-30	European Medicines Agency	Indication received approval from the European Commission.