Halozyme: Bristol Myers Gets New PDUFA Date For Subcutaneous Nivolumab Co-Formulated With ENHANZE

(RTTNews) - Halozyme Therapeutics, Inc. (HALO) said Bristol Myers Squibb was reassigned a Prescription Drug User Fee Act goal date from the FDA for their Biologics License Application for the subcutaneous formulation of Opdivo co-formulated with ENHANZE, Halozyme's recombinant human hyaluronidase enzyme, rHuPH20, across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib. The updated goal date is December 29, 2024.

The application is based on results from CheckMate-67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab with ENHANZE.

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