The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for GlaxoSmithKline's Mekinist (trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
Trametinib as a single agent has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy. Before taking trametinib, patients must have confirmation of BRAF V600 mutation using a validated test.
Dr Rafael Amado, head of oncology R&D at GSK said: “This CHMP opinion brings us a step closer to making another personalised medicine available for patients with BRAF-mutant metastatic melanoma in Europe.”
The CHMP recommendation for trametinib monotherapy is based on a randomised open label phase III study comparing trametinib to chemotherapy in 322 patients with BRAF mutant melanoma (V600E and V600K) and a non-randomised phase II study in 97 patients with BRAF mutant melanoma split in two cohorts: previously treated or not treated with a BRAF inhibitor.
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission (EC), but does not always result in marketing authorisation. A final decision by the EC is anticipated during the second quarter of 2014.
Mekinist is a MEK inhibitor that targets the MAPK pathway, which regulates the normal growth and death of cells, including skin cells and plays a role in metastatic melanoma development.
Mekinist is approved as a single agent and in combination with Tafinlar (dabrafenib) in the US and Australia. Mekinist is also approved as monotherapy in Canada.