European Medicines Agency Validates Bristol Myers Squibb’s Application for Subcutaneous Nivolumab
Bristol-Myers Squibb Company (BMY)
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Source: Business Wire
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 formulationApplication seeks approval for subcutaneous nivolumab formulation to treat multiple Opdivo adult solid tumor indications in the European Union PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated the extension application to introduce a new route of administration (subcutaneous use) for Opdivo® (nivolumab) that includes a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial) across multiple previously approved adult solid tumor indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib, based on the results from the Phase 3 CheckMate -67T stu
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