GSK submits sNDAs for melanoma drugs

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) submitted a pair of sNDAs 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. FDA approved both drugs as monotherapies in May. Tafinlar is approved to treat melanoma with BRAF V600E mutations as detected by an FDA-approved test, and Mekinist is approved to treat melanoma with BRAF V600E or V600K mutations (see BioCentury Extra, May 29). ...