FDA Approves Roche's Tecentriq Hybreza™ With ENHANZE® for Various Cancers

Halozyme Therapeutics, Inc. has announced that Roche received FDA approval for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs), utilizing Halozyme's ENHANZE® drug delivery technology. This significant development allows the subcutaneous administration of Tecentriq Hybreza™ in approximately seven minutes, a considerable reduction from the 30 to 60 minutes required for the intravenous (IV) infusion of Tecentriq® (atezolizumab). This new treatment option is available in the United States for all approved adult indications of intravenous Tecentriq®, which includes specific types of lung, liver, skin, and soft tissue cancers.

Tecentriq Hybreza™ combines atezolizumab, a monoclonal antibody targeting PD-(L)1 to combat cancer immune evasion, with Halozyme's recombinant human hyaluronidase enzyme, rHuPH20. Dr. Helen Torley, president and CEO of Halozyme, expressed her excitement over the FDA approval, noting that the ENHANZE® technology offers patients and physicians more flexibility and a new administration option.

The FDA's approval is based on pivotal data from Roche's Phase IB/III IMscin001 study. This study demonstrated that subcutaneous administration of Tecentriq® resulted in comparable blood levels and a safety and efficacy profile consistent with the IV formulation.

Halozyme Therapeutics is a biopharmaceutical company focused on improving patient experiences and outcomes for both emerging and established therapies. Halozyme's ENHANZE® drug delivery technology, featuring the proprietary enzyme rHuPH20, is designed to ease the subcutaneous delivery of injected drugs and fluids, enhancing patient experience with faster subcutaneous delivery and reduced treatment burden. The technology has been used in post-marketing applications across more than 100 global markets and has improved the lives of over 800,000 patients. Numerous renowned pharmaceutical and biotechnology companies, including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, and Acumen Pharmaceuticals, have licensed ENHANZE® technology.

In addition, Halozyme develops, manufactures, and commercializes drug-device combination products, either independently or with partners. These products are designed using advanced auto-injector technologies to offer commercial or functional benefits like improved convenience, reliability, tolerability, and enhanced patient comfort and adherence. Halozyme has two proprietary commercial products, Hylenex® and XYOSTED®, as well as various partnered commercial products and ongoing development programs with pharmaceutical companies such as Teva Pharmaceuticals and Idorsia Pharmaceuticals.

Halozyme is headquartered in San Diego, California, with additional offices in Ewing, New Jersey, and an operations facility in Minnetonka, Minnesota.