Array BioPharma Says FDA Accepts Binimetinib NDA

(RTTNews) - Array BioPharma (ARRY) announced that the FDA has accepted its New Drug Application or NDA for binimetinib with a target action date under the Prescription Drug User Fee Act or PDUFA of June 30, 2017.

Array completed its NDA submission of binimetinib in late June 2016 based on findings from the pivotal Phase 3 NEMO (NRAS MELANOMA AND MEK INHIBITOR) trial in patients with NRAS-mutant melanoma.

The FDA also indicated that it plans to hold an advisory committee meeting or ODAC as part of the review process. As previously reported, Array is currently preparing for an Application Orientation Meeting or AOM with the FDA in September 2016, which it expects will include a discussion of the NDA package including clinical risk / benefit.

The NEMO trial, (NCT01763164), is an international, randomized Phase 3 study evaluating the safety and efficacy of 45 mg BID binimetinib, compared to 1,000 mg/m2 dacarbazine dosed every three weeks. Prior immunotherapy treatment was allowed, and patients underwent radiographic assessment of disease status every six weeks. Assessment of progression was determined by blinded central review. Over 100 sites across North America, Europe, South America, Asia and Australia participated in the study.