BioCentury
ARTICLE | Company News

Regulatory round-up: Array, Sandoz, Sorrento, Adello

September 12, 2017 11:37 PM UTC

FDA accepted for review a number of applications, including NDAs from Array BioPharma Inc. (NASDAQ:ARRY) and BLAs for two biosimilar candidates.

FDA assigned a June 30, 2018 PDUFA date to a pair of NDAs from Array for binimetinib (MEK162) and encorafenib (LGX818) in combination to treat BRAF-mutant advanced, unresectable or metastatic melanoma. Last month, the company said it filed two NDAs since each compound will have separate labels, but is only seeking approval in combination. Pierre Fabre Group (Castres, France) has rights to binimetinib and encorafenib outside the U.S., Canada, Japan, South Korea and Israel. Binimetinib is a small molecule selective MAP kinase kinase 1 (MAP2K1; MEK1) and MEK2 inhibitor, and encorafenib is a small molecule BRAF inhibitor...