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.
Publications
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.
Relatlimab Plus Nivolumab Approaches EU Approval for Advanced Melanoma With PD-L1 of <1%
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of the fixed-dose combination of nivolumab (Opdivo) and relatlimab (Opdualog) for the frontline treatment of adult and adolescents who are 12 years of age or older with advanced melanoma and a tumor cell PD-L1 expression of less than 1%.