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Halozyme Announces Bristol Myers Squibb Received European Commission Approval for Subcutaneous Opdivo® (nivolumab) Co-Formulated with ENHANZE® Across Multiple Solid Tumor Indications
Opdivo® is the first and only PD-1 inhibitor approved for subcutaneous (SC) use in the European Union SAN DIEGO, May 28, 2025 /PRNewswire/ -- Halozyme
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"Opdivo® is the first and only PD-1 inhibitor approved for subcutaneous (SC) use in the European Union\nSAN DIEGO, May 28, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Bristol Myers Squibb received European Commission (EC) approval of a new Opdivo® (nivolumab) subcutaneous formulation developed with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous nivolumab plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.\n\"The European approval of Opdivo SC represents an advancement for certain cancer patients, who now have the option to receive their Opdivo as a 3-to-5-minute SC injection,\" said Dr. Helen Torley, president and chief executive officer of Halozyme. \"This approval is just one of the 11 growth catalysts for our commercialized SC products expected this year.\"\nThe positive EC decision 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 May 28, 2025.\nThe approval by the EC is valid in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway. \nOn December 27, 2024, subcutaneous 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 burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Li...