![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Array BioPharma’s Melanoma Candidate Meets Primary Endpoint
Array BioPharma’s Melanoma Candidate Meets Primary Endpoint
December 22, 2015
Array BioPharma’s binimetinib met the primary endpoint of improved progression-free survival in a Phase 3 study in patients with advanced NRAS-mutant melanoma.
Median PFS on the binimetinib arm was 2.8 months versus 1.5 months on comparator dacarbazine. Binimetinib also is being studied in Phase 3 trials in BRAF-mutant melanoma and ovarian cancer.
Array plans to submit an NDA during the first half of 2016.
Upcoming Events
-
21Oct