CHMP adopts a positive opinion for Mekinist (trametinib) in thyroid cancer – Novartis

The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Mekinist.

The marketing authorisation holder for this medicinal product is Novartis Europharm Limited. The CHMP adopted a new indication as follows: Trametinib ( Mekinist )  in combination with dabrafenib (Tafinlar) is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.