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European committee recommends marketing Mekinist monotherapy for metastatic melanoma

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The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing authorization for trametinib monotherapy for adults with unresectable or metastatic melanoma with BRAFV600 mutation, GlaxoSmithKline announced.

“This CHMP [Committee for Medicinal Products for Human Use] opinion brings us a step closer to making another personalized medicine available for patients with BRAF-mutant metastatic melanoma in Europe,” Rafael Amado, MD, head of Oncology R&D at GlaxoSmithKline, said in a news release.

Trametinib (Mekinist), a MEK inhibitor that targets the MAPK pathway and regulates normal growth and death of cells, including skin cells that play a role in metastatic melanoma development, was recommended based on results of two studies. In the randomized, open-label phase 3 study, trametinib was compared with chemotherapy in 322 patients with BRAF mutant melanoma (V600E and V600K), while in the nonrandomized phase 2 study, 97 patients with BRAF mutant melanoma were divided into groups of those previously treated and those not treated with a BRAF inhibitor.

The CHMP opinion is one of the final steps before marketing authorization by the European Commission (EC). A final decision by the EC is expected in the second quarter.

Trametinib has been approved by the FDA as a single agent and in combination with dabrafenib (Tafinlar, GlaxoSmithKline) for treating metastatic or unresectable melanoma.