FDA Approves Bristol-Myers' Opdualag, First LAG-3-Blocking Antibody Combo, For Melanoma Patients

The FDA approved Bristol-Myers Squibb & Co's BMY fixed-dose combination of nivolumab and relatlimab, Opdualag, for patients 12 years of age or older with unresectable or metastatic melanoma.

• The approval is based on the Phase 2/3 RELATIVITY-047 trial, which compared Opdualag (n=355) to nivolumab alone (n=359).
• The trial met its primary endpoint, progression-free survival (PFS). Opdualag more than doubled the median PFS compared to nivolumab monotherapy, 10.1 months versus 4.6 months.
• The Opdualag safety profile was similar to that previously reported for nivolumab. No new safety events were identified with the combination compared to nivolumab monotherapy.
• Read Next: Bristol Myers, Nektar Melanoma Doublet Therapy Trial Fails To Show Clinical Benefit.
• Opdualag carries risks such as severe and fatal immune-mediated adverse reactions, infusion-related reactions, allogeneic hematopoietic stem cell transplantation complications, and embryo-fetal toxicity.
• The FDA-approved dosing for adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg is 480 mg nivolumab and 160 mg relatlimab administered intravenously every four weeks.
• Price Action: BMY shares closed 0.71% higher at $71.02 on Friday.