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FDA accepts Array's binimetinib NDA
September 1, 2016 7:00 AM UTC
Array BioPharma Inc. (NASDAQ:ARRY) said FDA accepted for filing an NDA for binimetinib ( MEK162) to treat advanced neuroblastoma Ras viral (v-Ras) oncogene (NRAS)-mutant melanoma. The PDUFA date is June 30, 2017. Array said FDA plans to hold an advisory meeting to discuss the application for the small molecule inhibitor of selective MAP kinase kinase 1 ( MAP2K1; MEK1) and MEK2.
Last year, binimetinib met the primary endpoint in the Phase III NEMO trial to treat NRAS-mutant melanoma (see BioCentury Extra, Dec. 16, 2015). ...