EU Gives GSK Permission to Market Mekinist

Some melanoma patients in the EU will now have access to GlaxoSmithKline’s Mekinist, following the European Commission’s approval of the drug as a single agent for patients with unresectable or metastatic disease fueled by a BRAF V600 mutation.

The decision, announced by GSK on July 4, was based largely on results of a Phase III study that showed that BRAF-mutant melanoma patients on Mekinist (trametinib) experienced an extra 3.3 months of median progression-free survival compared with patients on chemotherapy.

GSK also submitted results of a Phase II trial that looked at objective response rate, safety and pharmacokinetics in 97 patients with V600E, V600K, or V600D mutations who were dosed with 2 mg of Mekinist.

Based on those results, the European Medicines Agency’s Committee for Medicinal Products for Human Use gave the drug a thumbs-up recommendation in April. Mekinist is the first MEK inhibitor on the market.

The FDA approved Mekinist and a second GSK drug, Tafinlar (dabrafenib), as monotherapies last summer for unresectable or metastatic melanoma with BRAF V600 mutations, then greenlighted them in January as a combination therapy for patients with BRAF V600E or V600K mutations.

U.S. sales of Mekinist reached $17.1 million last year, while Tafinlar garnered $27.4 million.

GSK’s melanoma combination therapy earlier this year hit a bump on the road to EU authorization. A month before CHMP recommended Mekinist, GSK withdrew its marketing authorization application for the Mekinist/Tafinlar duo after CHMP declined to recommend it, citing insufficient data to determine a definitive benefit-risk ratio.

The company plans to resubmit its application to the EMA, pending the results of two Phase III trials. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.