Bristol Myers' Opdivo Combo Treatment Scores European Approval For Skin Cancer Setting

  • The European Commission approved Bristol Myers Squibb & Co's BMY fixed-dose combination of Opdualag (nivolumab and relatlimab) for melanoma patients aged 12 years and above.
  • Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) in the skin.
  • The approval covers the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents with tumor cell PD-L1 expression < 1%.
  • Also Read: Melanoma Study Achieves Key Milestone as Bristol's Flagship Treatment Secures Improvement in Survival Rates.
  • The decision is based upon an exploratory analysis of results from the Phase 2/3 RELATIVITY-047 trial, which demonstrated that treatment with the fixed-dose combination med more than doubled the median progression-free survival (PFS) compared to nivolumab monotherapy – an established standard of care. 
  • No new safety events were identified with the combination compared to nivolumab monotherapy.
  • Price Action: BMY shares closed 0.36% lower at $71.52 on Friday.
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Posted In: BiotechLarge CapNewsHealth CareGeneralBriefsEurasiaEuropean Medicines Agency
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