share_log

Halozyme Discloses That Bristol Myers Squibb Received Updated Action Date From U.S. FDA For Subcutaneous Nivolumab Co-Formulated With ENHANZE (Halozyme's Proprietary Recombinant Human Hyaluronidase Enzyme); The Updated Goal Date Is December 29, 2024

Benzinga ·  May 21 19:55

Halozyme announced that Bristol Myers Squibb was reassigned a Prescription Drug User Fee Act goal date from the U.S. Food and Drug Administration for their Biologics License Application for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with ENHANZE, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) 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 to evaluate and demonstrate noninferior pharmacokinetics, efficacy and consistent safety vs. its intravenous formulation. If approved, subcutaneous nivolumab has the potential to be the first and only subcutaneously administered PD-1 inhibitor.

The above content is for informational or educational purposes only and does not constitute any investment advice related to Futu. Although we strive to ensure the truthfulness, accuracy, and originality of all such content, we cannot guarantee it.
    Write a comment