GSK seeks approval of dabrafenib, trametinib

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) submitted regulatory applications for dabrafenib and trametinib, including NDAs to FDA for both products to treat patients with unresectable or metastatic melanoma with BRAF V600 mutations. GSK also submitted an MAA to EMA for dabrafenib in the indication and plans to submit a European application for trametinib "in the coming months." Partner bioMerieux S.A. (Euronext:BIM) submitted a PMA to FDA for a companion diagnostic to detect BRAF V600E and V600K mutations (see BioCentury, June 11). ...