Bristol Myers Squibb Scores Three Back To Back European Approvals For Opdivo In Esophageal, Urothelial Cancer

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The European Commission (EC) has approved Bristol Myers Squibb Co's BMY Opdivo (nivolumab) plus Yervoy (ipilimumab) combo for esophageal squamous cell carcinoma (ESCC).

  • The approval covers the combo therapy as first-line treatment of adult patients with unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression ≥ 1%. 
  • The EC has also approved Opdivo with fluoropyrimidine- and platinum-based chemotherapy for the same indication in esophageal cancer.
  • The EC also approved Opdivo for the adjuvant treatment of urothelial carcinoma.
  • The approval covers adults with muscle-invasive urothelial carcinoma with tumor cell PD-L1 expression ≥1% who are at a high risk of recurrence after undergoing radical resection. 
  • With this EC decision, Opdivo became the first adjuvant immunotherapy option approved for patients in the European Union (EU) in this setting.
  • Price Action: BMY shares are up 1.37% at $74.80 during the market session on the last check Tuesday.
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Posted In: BiotechNewsHealth CareGeneralBriefsEuropean Medicines Agency
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