GSK receives EU approval for Mekinist for melanoma

The European Commission has granted marketing authorization for UK pharma giant GlaxoSmithKline’s (LSE: GSK) Mekinist(trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Trametinib has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy. Before taking trametinib, patients must have confirmation of a BRAF V600 mutation using a validated test.

Paolo Paoletti, president of oncology at GSK, said: “We welcome today’s decision of the European Commission. MEK has been pursued as a therapeutic target in cancer for more than a decade, and Mekinist is the first medicine in this class to be licensed in Europe.”