Mekinist trametinib regulatory update

EMA's CHMP backed approval of Mekinist trametinib from GlaxoSmithKline as monotherapy to treat unresectable or metastatic melanoma in adults with a BRAF V600 mutation. GSK expects a decision on the MAA this quarter. Last month, GSK withdrew an MAA for Mekinist in combination with its 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 (see BioCentury, March 31). The European Commission approved Tafinlar as monotherapy last year.

Mekinist and Tafinlar are approved in the U.S. as monotherapies and in combination for metastatic melanoma (see BioCentury, Jan. 13). GSK in-licensed Mekinist - a small molecule inhibitor of MAP kinase kinase 1 ( MAP2K1; MEK1) and MEK2 - from Japan Tobacco. Tafinlar is an oral BRAF protein kinase inhibitor. ...