Posted by Michael Wonder on 20 Mar 2017
Array BioPharma provides update on FDA submission for binimetinib
20 March 2017 - NRAS mutant melanoma NDA withdrawn based on thorough discussions with FDA and following late cycle review meeting.
Array BioPharma today announced that it has withdrawn from the U.S. FDA Division of Oncology Products 2 its new drug application for binimetinib monotherapy for the treatment of NRAS-mutant melanoma, a rare, mutationally-driven subset of skin cancer.
This action was based on thorough discussions and communications with the FDA, including exploration of various paths to approval, and followed the late cycle review meeting held with the FDA on 17 March 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.
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.
