Array Biopharma Retracts Its New Drug Application For Binimetinib Monotherapy
Array Biopharma has withdrawn its new drug application for binimetinib monotherapy for the treatment of NRAS-mutant melanoma, a rare, mutation-driven subset of skin cancer.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.