GSK announces delay in Mekinist/Tafinlar MAA; EU approval of Eperzan

27 March 2014

UK pharma giant GlaxoSmithKline (LSE: GSK) released a couple of news items yesterday, one slightly negative regarding a melanoma combination product filing in Europe and the other announcing approval of a new diabetes treatment.

GSK says it has withdrawn its Marketing Authorization Application (MAA) to the European Medicines Agency for the use of Mekinist (trametinib) in combination with the previously approved BRAF inhibitor Tafinlar (dabrafenib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The application for the use of Mekinist as a single agent in the same patient population, submitted simultaneously with the MAA for the combination, is still undergoing review by the EMA.

The EMA Committee for Medicinal Products for Human Use (CHMP) has indicated that the data provided to date by GSK did not allow it intends to re-submit the MAA for the combined use of Tafinlar and Mekinist when additional data from the ongoing Phase III program become available.

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