On September 12, 2024 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported that Roche received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) with Halozyme’s ENHANZE drug delivery technology (Press release, Halozyme, SEP 12, 2024, View Source [SID1234646540]). Tecentriq Hybreza can be injected subcutaneously in approximately 7 minutes compared to 30-60 minutes for standard intravenous (IV) infusion of Tecentriq (atezolizumab). The treatment will be available in the U.S. for all approved adult indications of intravenous Tecentriq, including certain types of lung, liver, skin and soft tissue cancer.

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Tecentriq Hybreza is a subcutaneous product combination of atezolizumab, a monoclonal antibody that targets PD-(L)1 aiming to prevent cancer immune evasion, and Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20.

"We are delighted that Tecentriq Hybreza has been approved in the U.S. for all approved adult indications of the IV treatment," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This approval represents another opportunity for our ENHANZE technology to provide patients and physicians with greater flexibility and a new option for how treatment is administered."

The FDA approval is based on pivotal data from Roche’s 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.