FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Array Biopharma Retracts Its New Drug Application For Binimetinib Monotherapy

March 27, 2017

Array Biopharma has withdrawn its new drug application for binimetinib monotherapy for the treatment of NRAS-mutant melanoma, a rare, mutation-driven subset of skin cancer.

Array concluded from a meeting with the FDA that the clinical benefit demonstrated in the phase 3 clinical trial would not be found sufficient to support approval of the NDA.

The company said the withdrawal will not impact the planned phase 3 Columbus trial NDA of binimetinib, in combination with encorafenib, for the treatment of BRAF-mutant melanoma, which remains on track for mid-2017.

NRAS mutations are present in approximately 20 percent of the estimated 10,000 annual cases of metastatic melanoma in the United States. 

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