BioCentury
ARTICLE | Clinical News

Binimetinib regulatory update

March 21, 2017 9:31 PM UTC

Array withdrew its NDA for binimetinib 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. The PDUFA date was June 30. Array said that following discussions with FDA, the company concluded that the clinical benefit shown in the Phase III NEMO trial “would not be found sufficient to support approval” in the indication. In NEMO, binimetinib met the primary endpoint of improving progression-free survival (PFS) (2.8 vs. 1.5 months, p<0.001), but missed the secondary endpoint of improving median overall survival (OS) (11 vs. 10.1 months, p=0.499) vs. dacarbazine (see BioCentury, Dec. 21, 2015)...