CHMP recommends Mekinist for Metastatic Melanoma - Glaxo Smith Kline
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Mekinist (trametinib), from Glaxo Smith Kline, 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.
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 final decision by the EC is anticipated during the second quarter of 2014.
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