Array withdraws binimetinib NDA

Array BioPharma Inc. (NASDAQ:ARRY) said it withdrew its NDA for binimetinib (MEK162) monotherapy to treat neuroblastoma Ras viral (v-Ras) oncogene (NRAS)-mutant melanoma. FDA's Oncologic Drugs Advisory Committee was to discuss the candidate's NDA at a March 29 meeting.

Array said that after "thorough discussions and communications" with FDA, it concluded that the clinical benefit shown in the Phase III NEMO trial "would not be found sufficient to support approval" in the indication. In December 2015, Array said binimetinib improved progression-free survival over dacarbazine, meeting NEMO's primary endpoint (see BioCentury Extra, Dec. 16, 2015)...