FDA accepts Array BioPharma NDA for binimetinib

Array BioPharma announced last week that its New Drug Application (NDA) for binimetinib has been accepted by the U.S. Food and Drug Administration (FDA).

The target action date, per the Prescription Drug User Fee Act (PDUFA), is June 30 of next year.

The NDA for binimetinib was submitted in June and was based on the results from the NRAS MELANOMA AND MEK INHIBITOR (NEMO) pivotal Phase 3 trial, which was conducted on patients suffering from NRAS-mutant melanoma. As part of the review process, the FDA will hold an advisory committee meeting (ODAC).

"There are very few treatment advances beyond immunotherapy for this devastating disease, which impacts one out of five advanced melanoma patients," Array BioPharma CMO Dr. Victor Sandor said. "Binimetinib is the first and only MEK inhibitor to demonstrate improvement on progression free survival in a Phase 3 trial for NRAS mutant melanoma patients."

Currently, Array BioPharma is preparing an Application Orientation Meeting (AOM), which will be held with the FDA this month. The meeting will hold a discussion of the NDA package, including clinical risk and benefits of the drug.