08:19 AM EDT, 06/21/2024 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said Friday the European Medicines Agency has validated its extension application to introduce subcutaneous administration of its cancer treatment, Opdivo.
The extension application includes a new 600 mg/vial injection for various solid tumours as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib.
The decision, based on results of a phase 3 study, confirms Bristol-Myers' submission as complete, and starts the European health agency's centralized review procedure, the company said.
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