Array (ARRY) Oncology Drug Accepted For Review In The U.S.
Zacks Investment Research | Sep 01, 2016 09:29PM ET
Array BioPharma (NASDAQ:ARRY) announced that the FDA has accepted a New Drug Application (NDA) for its pipeline candidate, binimetinib.
The NDA was submitted in Jun 2016 based on positive results from the phase III trial, NEMO, which compared binimetinib with dacarbazine in unresectable or metastatic NRAS-mutant melanoma patients. The study met its primary endpoint of improving progression-free survival (PFS), compared with dacarbazine treatment.
The FDA has given a Prescription Drug User Fee Act (PDUFA) of Jun 30, 2017. As part of the review process, the agency plans to hold an advisory committee meeting.
We note that Array is currently preparing for an Application Orientation Meeting with the FDA scheduled for Sep 2016. The company plans to discuss the NDA package with the regulatory agency, including the candidate’s clinical risk/benefit profile, at the meeting.
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