The FDA granted an expanded approval to Opdivo (nivolumab) as a single agent and in combination with Yervoy (ipilimumab) on January 23 for the treatment of patients with melanoma who harbor BRAF V600 mutations. As a result of the expansion, Opdivo is now available as a frontline treatment for all patients with advanced melanoma, regardless of BRAF status.
Regulatory
FDA grants orphan drug designation to IMCgp100 for uveal melanoma
The FDA granted orphan drug designation to IMCgp100 for the treatment of uveal melanoma.
IMCgp100 (Immunocore) is part of a class of bispecific biologic reagents known as ImmTACs, or immune-mobilizing monoclonal T-cell receptors against cancer.
Opdivo Plus Yervoy Gets FDA OK for Melanoma
WASHINGTON — Indications for the blockbuster cancer drug nivolumab (Opdivo) have expanded again, as the FDA has approved the anti-PD-1 antibody in combination with ipilimumab (Yervoy) for treatment of unresectable or metastatic melanoma.
FDA expands approval of Opdivo plus Yervoy for melanoma
The FDA expanded the approval of nivolumab plus ipilimumab to include all patients with unresectable or metastatic melanoma, regardless of BRAF V600 mutational status.