Pharma Focus America

Halozyme Announces FDA's Revised Action Date for Bristol Myers Squibb's Subcutaneous Nivolumab Combined with ENHANZE®

Wednesday, May 22, 2024

Halozyme Therapeutics, Inc. (NASDAQ: HALO) disclosed today that the U.S. Food and Drug Administration (FDA) has reset Bristol Myers Squibb's goal date under the Prescription Drug User Fee Act. This concerns their Biologics License Application for the subcutaneous formulation of Opdivo® (nivolumab) co-formulated with ENHANZE®, leveraging Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20. This application encompasses all previously approved adult, solid tumor Opdivo indications, whether as monotherapy, monotherapy maintenance after Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The new goal date for this application review is December 29, 2024.

This application builds upon data from CheckMate-67T, the inaugural Phase 3 trial of the subcutaneous formulation of nivolumab with ENHANZE®. This study seeks to assess and establish noninferior pharmacokinetics, efficacy, and consistent safety compared to its intravenous counterpart. If approved, subcutaneous nivolumab could potentially become the first and only PD-1 inhibitor administered subcutaneously.



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