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www.fdanews.com/articles/165721-eu-gives-gsk-permission-to-market-mekinist

EU Gives GSK Permission to Market Mekinist

July 10, 2014

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.