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The European Medicines Agency Has Validated The Extension Application To Introduce Subcutaneous Administration For Bristol Myers Squibb's Opdivo (Nivolumab) And A New Strength (600 Mg/Vial) Across Multiple Previously Approved Adult Solid Tumor Indications

Benzinga ·  Jun 21 19:03
  • Validation is based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation of Opdivo to evaluate and demonstrate noninferior pharmacokinetics and efficacy vs. its intravenous formulation
  • Application seeks approval for subcutaneous nivolumab formulation to treat multiple Opdivo adult solid tumor indications in the European Union
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