Losing Nemo: Array pulls skin cancer NDA for binimetinib
Source: Fierce Biotech, March 2017
Array BioPharma has yanked its NDA to the U.S. regulator for its late-stage melanoma candidate binimetinib after the agency told the biotech its phase 3 Nemo data wouldn’t cut it.
The med was seeking a licence to treat a rare form of this deadly skin cancer, known as NRAS-mutant melanoma, but after talks with the FDA about Nemo, Array said it: “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.” Its PDUFA date had been at the end of June this year.
These data, posted last summer, showed that the drug was not too much better than older chemotherapy med dacarbazine, where its objective response rate was 15% for binimetinib versus 7% for dacarbazine, while median overall survival was estimated at 11 months for the experimental med, but 10.1 months for chemo.