Categorized | Melanoma In The News, FDA

FDA accepts new drug application for binimetinib for advanced NRAS-mutant melanoma

Source: Healio, September 2016

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.”

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