Bristol-Myers Squibb reports that the U.S. FDA has accepted its Biologics License Application (BLA) for the subcutaneous formulation of Opdivo in all previously approved indications for Opdivo in adult solid tumors.

This application is based on the results of CheckMate -67T, a Phase III trial conducted to evaluate and demonstrate the consistent, non-inferior pharmacokinetics, efficacy and safety of the subcutaneous formulation compared with the intravenous formulation.

Opdivo (nivolumab), the Group's flagship drug, could thus become the first and only PD-1 inhibitor to be administered subcutaneously. The FDA has set the Prescription Drug User Fee Act (PDUFA) deadline at February 28, 2025.

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