On January 16, 2024 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported that Roche received European Commission (EC) marketing authorization of Tecentriq SC (atezolizumab) co-formulated with ENHANZE, Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20 (Press release, Halozyme, JAN 16, 2024, View Source [SID1234639276]). 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.
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Tecentriq 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.
"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.
The 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 formulation.