GSK's Mekinist gets FDA approval for Tafinlar combo

FDA granted accelerated approval late Wednesday to an sNDA from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) expanding the label for melanoma drug Mekinist trametinib to include its combination use with Tafinlar dabrafenib to treat adults with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation as detected by an FDA-approved test. A decision on an sNDA to add the combo to Tafinlar's label is expected Thursday. FDA approved both drugs as monotherapies in May; GSK has launched both in the U.S. (see BioCentury Extra, May 29, 2013). ...