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Halozyme Announces Bristol Myers Squibb Received Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) with ENHANZE® Across Multiple Solid Tumor Indications
A decision on the European marketing authorization extension for the subcutaneous formulation of Opdivo is expected by June 2, 2025 SAN DIEGO, March 31, 2025
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"A decision on the European marketing authorization extension for the subcutaneous formulation of Opdivo is expected by June 2, 2025\nSAN DIEGO, March 31, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Bristol Myers Squibb received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending approval of a new Opdivo® (nivolumab) subcutaneous formulation developed with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), across multiple previously approved adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.\nThe CHMP opinion will now be reviewed by the European Commission, which has the authority to approve medicines in the European Union. A decision on the European extension of marketing authorization for the subcutaneous formulation of Opdivo is expected by June 2, 2025.\n\"We are delighted that the subcutaneous formulation of Opdivo developed with Halozyme's ENHANZE drug delivery technology was recommended for approval in the European Union. Subcutaneous delivery of Opdivo would provide cancer patients a faster and more flexible treatment option and may help alleviate pressure on healthcare system resources,\" said Dr. Helen Torley, president and chief executive officer of Halozyme.\nThe CHMP positive opinion is supported by positive results from the Phase 3 CheckMate -67T trial. For more information on the study and its findings, please view Bristol Myers Squibb's press release issued on March 28, 2025.\nOn December 27, 2024, nivolumab and hyaluronidase-nvhy, marketed under the brand name Opdivo Qvantig, was approved by the U.S. Food and Drug Administration.\nAbout Halozyme\nHalozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burde...