Priority Review for GSK's Tafinlar and Mekinist melanoma combination

FDA accepted and granted Priority Review to a pair of sNDAs from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to expand the labels for melanoma drugs Tafinlar dabrafenib and Mekinist trametinib to include their combination use to treat adults with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. The PDUFA dates are Jan. 8, 2014, for Mekinist and Jan. 9, 2014, for Tafinlar. FDA approved both drugs as monotherapies in May. Tafinlar is approved to treat melanoma with BRAF V600E mutation, and Mekinist is approved to treat melanoma with BRAF V600E or V600K mutations (see BioCentury Extra, May 29). ...