EMA validates MAA for binimetinib/encorafenib in melanoma

Pierre Fabre Group (Castres, France) said EMA validated an MAA for binimetinib (MEK162) and encorafenib (LGX818) in combination to treat BRAF-mutant advanced, unresectable or metastatic melanoma.

The combination is also under FDA review for the indication with a June 30, 2018 PDUFA date. Encorafenib is a small molecule BRAF inhibitor, and binimetinib is a small molecule selective MAP kinase kinase 1 (MAP2K1; MEK1) and MAP2K2 (MEK2) inhibitor...