The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for binimetinib (Array BioPharma) for the treatment of NRAS-mutant melanoma.

The company’s NDA submission was supported by data from the NEMO (NRAS MELANOMA AND MEK INHIBITOR) study, an international, randomized, Phase 3 trial evaluating the safety and efficacy of binimetinib 45mg twice daily vs. dacarbazine 1,000 mg/m2 every 3 weeks in patients with NRAS-mutant melanoma. The study met its primary endpoint of improving progression-free survival (PFS), demonstrating a median PFS of 2.8 months in the binimetinib arm vs. 1.5 months in the dacarbazine arm. In addition, treatment with binimetinib also showed improvement in overall response rate (ORR) and disease control rate. Detailed results from the study were presented at the 2016 ASCO Annual Meeting. 

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The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2017 to make a decision on the NDA. The agency also indicated that it intends to hold an advisory committee meeting (ODAC) as part of the application review process.

Binimetinib is a late-stage, small molecule MEK inhibitor designed to target protein kinases that regulate cell proliferation, differentiation, survival and angiogenesis in the MAPK signaling pathway.

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