New Zealand’s Pharmaceutical Management Agency, or PHARMAC, has given a reimbursement approval for Bristol-Myers Squibb’s ($BMY) Opdivo (nivolumab) to treat melanoma, while still in a back-and-forth with Merck ($MRK) on Keytruda (pembrolizumab) for the same indication.
Publications
Losing Nemo: Array pulls skin cancer NDA for binimetinib
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.
Immunocore wins FDA nod for first uveal melanoma treatment, also first T-cell receptor therapeutic
Uveal melanoma, an aggressive cancer of the eye, has been a particularly tough nut to crack for scientists trying to find a treatment.
FDA Approval Sought for Lifileucel in Advanced Melanoma
A rolling biologics license application (BLA) seeking the approval of lifileucel (LN-44) in patients with advanced melanoma who progressed on or after previous anti–PD-1/PD-L1 therapy, and if BRAF mutation positive, also previous BRAF or BRAF/MEK inhibitor therapy, has been submitted to the FDA.