CHMP backs Mekinist as monotherapy

EMA's CHMP backed approval of Mekinist trametinib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) as monotherapy to treat unresectable or metastatic melanoma in adults with a BRAF V600 mutation. Last month, GSK withdrew an MAA for Mekinist in combination with Tafinlar dabrafenib for the indication after EMA's CHMP could not "conclude on a positive benefit-risk balance of the combination" based on data provided by GSK. The European Commission approved Tafinlar as monotherapy last year. The melanoma drugs are approved in the U.S. as monotherapies and in combination. Mekinist is a small molecule inhibitor of MAP kinase kinase 1 ( MAP2K1; MEK1) and MEK2, and Tafinlar is an oral BRAF protein kinase inhibitor (see BioCentury Extra, March 26). ...