On August 29, 2023 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") reported the approval of Roche’s Tecentriq SC (atezolizumab), using Halozyme’s ENHANZE drug delivery technology, by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain (Press release, Halozyme, AUG 29, 2023, View Source [SID1234634755]). Tecentriq subcutaneous (SC) is co-formulated with Halozyme’s proprietary recombinant human hyaluronidase enzyme, rHuPH20, allowing for subcutaneous delivery, which takes approximately seven minutes, compared with 30-60 minutes for intravenous (IV) infusion. Tecentriq SC will be available to patients in Great Britain for certain types of lung, bladder, breast, and liver cancer.7
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Multiple oncology studies suggest that most cancer patients prefer to receive their treatments via subcutaneous delivery, instead of intravenous infusion because of reduced discomfort, ease of administration, and shorter duration of treatment.2,4,11
"We are delighted that Roche has received approval of Tecentriq SC in Great Britain. Subcutaneous delivery of Tecentriq provides cancer patients a faster and more flexible treatment option and may alleviate pressure on healthcare system resources," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to additional regulatory approvals of our partner products utilizing ENHANZE."
Tecentriq SC is the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain and is Roche’s fourth subcutaneous cancer therapy using Halozyme’s ENHANZE drug delivery technology.8-10 The approval is based on clinical 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.12 While the IMscin001 trial was conducted within the hospital setting, the SC formulation may be suitable for out-of-hospital administration by a healthcare professional.
The U.S. Food and Drug Administration (FDA) is currently evaluating Tecentriq SC for regulatory approval.