FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Array Biopharma Retracts Its New Drug Application For Binimetinib Monotherapy

March 27, 2017
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Array Biopharma has withdrawn its new drug application for binimetinib monotherapy for the treatment of NRAS-mutant melanoma, a rare, mutation-driven subset of skin cancer.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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