Binimetinib Application for NRAS-Mutant Melanoma Withdrawn

March 20, 2017 – Array BioPharma has withdrawn its new drug application (NDA) for the MEK inhibitor binimetinib as a treatment for patients with NRAS-mutant advanced melanoma, based on feedback from the FDA during a preplanned review meeting. The application for binimetinib was based on data from the phase III NEMO study, which was presented at the 2016 ASCO Annual Meeting. In the open-label study, median progression-free survival (PFS) with binimetinib … (leggi tutto)