The FDA has accepted Array BioPharma’s new drug application for binimetinib for treating patients with NRAS-mutant melanoma, according to a press release from the company.
The new drug application (NDA) submission was completed by Array in June based on phase 3 NEMO study findings, according to the release. The FDA indicated it plans to hold an advisory committee meeting as part of the process and has set a target action date under the Prescription Drug User Fee Act of June 30, 2017.
“There are very few treatment advances beyond immunotherapy for this devastating disease, which impacts one out of five advanced melanoma patients,” Victor Sander, MD, chief medical officer, Array Biopharma, stated in the release. “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.”
In the phase 3 NEMO trial, researchers evaluated safety and efficacy of 45 mg twice-daily binimetinib, a late-stage small molecule MEK inhibitor, compared with1,000 mg/m2 dacarbazine every 3 weeks in patients at more than 100 sites across North America, Europe, South America, Asia and Australia.
Primary endpoint of improving progression-free survival (PFS) in the binimetinib arm compared with dacarbazine treatment was met. The median PFS in patients treated with binimetinib treatment was 2.8 months compared with 1.5 months for the dacarbazine treatment, according to the release.
In a subset of patients who had received prior immunotherapy treatment, the median PFS among patients in the binimetinib treatment group was 5.5 months compared with 1.6 months for patients receiving dacarbazine treatment.
Adverse events reported for binimetinib treatment were consistent with previous results in patients with NRAS-mutant melanoma, and the binimetinib treatment was generally well-tolerated, according to the release.
Binimetinib is currently not approved for use in any country, according to Array Biopharma.