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Bristol Myers: deadline set for subcutaneous Opdivo

( - Bristol Myers Squibb announces that the U.
S. FDA has reassigned its Biologics License Application (BLA) deadline for the subcutaneous formulation of Opdivo (nivolumab and hyaluronidase) to December 29.

This BLA covers all indications for Opdivo in adult solid tumors already approved as monotherapy, as maintenance monotherapy after completion of Opdivo plus Yervoy, or in combination with chemotherapy or cabozantinib.

This application is based on the results of CheckMate -67T, the first Phase 3 trial conducted to evaluate this formulation and demonstrate consistent non-inferior pharmacokinetics, efficacy and safety compared to the intravenous formulation.

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