The Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain has approved Roche’s Tecentriq SC (atezolizumab) using Halozyme’s ENHANZE drug delivery technology.

Tecentriq subcutaneous (SC) is co-formulated with Halozyme’s 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 lungs, bladder, breast, and liver cancer.

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. 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. 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. FDA is currently evaluating Tecentriq SC for regulatory approval.

“We are delighted that Roche has received approval of Tecentriq SC in Great Britain,” said Helen Torley, President and CEO of Halozyme. “Subcutaneous delivery of Tecentriq provides cancer patients a faster and more flexible treatment option and may alleviate pressure on healthcare system resources. We look forward to additional regulatory approvals of our partner products utilizing ENHANZE.”