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

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.

Posted In: BriefsEuropean Medicines AgencyBiotechNewsHealth CareGeneral

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