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Roche’s Tecentriq Hybreza Gets FDA Approval for Subcutaneous Use

Tecentriq Hybreza can be administered in about 7 minutes and leverages Halozyme's ENHANZE drug delivery technology.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Roche has obtained approval from the U.S. Food and Drug Administration (FDA) for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) utilizing Halozyme’s ENHANZE drug delivery technology.
 
Tecentriq Hybreza can be administered subcutaneously in about 7 minutes, in contrast to the standard intravenous (IV) infusion of Tecentriq (atezolizumab), which takes 30-60 minutes. This treatment will be available in the U.S. for all approved adult indications of intravenous Tecentriq, including specific types of lung, liver, skin, and soft tissue cancers.
 
Tecentriq Hybreza is a subcutaneous product combining atezolizumab, a monoclonal antibody targeting PD-(L)1 to prevent cancer immune evasion, with 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 CEO 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.

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