Array BioPharma exits 2 new FDA drug applications for a skin cancer
March 20, 2017Array BioPharma said on Sunday it has exited the U.S. Food and Drug Administration’s (FDA) Division of Oncology Products 2 its new drug application (NDA) for binimetinib monotherapy for the treatment of NRAS-mutant melanoma, a rare, mutationally-driven subset of skin cancer.
According to Array, the company did it after talking with the FDA about it, which covered exploration of various paths to approval, and followed the late cycle review meeting held with the FDA on Friday, March 17, 2017. Based on feedback from the agency, Array concluded that the clinical benefit demonstrated in the Phase 3 NEMO clinical trial would not be found sufficient to support approval of the NRAS-mutant melanoma NDA, the company said.
In addition,Array said the ongoing clinical trials for binimetinib will continue. “This action 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,” Array said in its press release.
