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Halozyme Announces Roche Receives European Commission Approval of Tecentriq® SC with ENHANZE® Representing the EU's First Subcutaneous PD-(L)1 Cancer Immunotherapy for Multiple Cancer Types
Reduces treatment time by approximately 80% compared to standard intravenous (IV) infusion Subcutaneous (SC) injection offers the potential for a faster, more
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"Reduces treatment time by approximately 80% compared to standard intravenous (IV) infusion\nSubcutaneous (SC) injection offers the potential for a faster, more convenient alternative to IV infusion and is preferred by patients and healthcare practitioners1 - 6\nSAN DIEGO, Jan. 16, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (\"Halozyme\") today announced that Roche received European Commission (EC) marketing authorization of Tecentriq® SC (atezolizumab) co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20. The approval applies to all approved indications of Tecentriq® IV and represents the European Union (EU)'s first PD-(L)1 cancer immunotherapy for subcutaneous injection.\nTecentriq® SC reduces treatment time to approximately 7 minutes, compared to an IV infusion which can take approximately 30 to 60 minutes. In addition, it may be administered by a healthcare professional outside of the hospital, in a community care setting or at home, depending on national regulations and health systems.\n\"As the first subcutaneous PD-(L)1 cancer immunotherapy in Europe, Tecentriq SC can provide a new treatment option that can enhance the treatment experience for patients and caregivers while freeing up resources in constrained healthcare systems,\" said Dr. Helen Torley, president and chief executive officer of Halozyme.\nThe EC approval follows pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq® in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. The study found 90% of healthcare professionals agreed that the SC formulation is easy to administer and 75% said it could save time for healthcare teams compared with the IV formulation6.\nAbout Halozyme \nHalozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 800,000 patient lives in post-marketing use in seven commercialized products across more t...