Halozyme Announces US FDA Approval of Roche's Tecentriq Hybreza with Enhanze

Halozyme announces US FDA approval of Roche's Tecentriq Hybreza with Enhanze for multiple types of cancer

Overview

Halozyme Therapeutics, Inc. (Halozyme) announced that Roche received US Food and Drug Administration (FDA) approval for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) with Halozyme's Enhanze drug delivery technology. 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 US for all approved adult indications of intravenous Tecentriq, including certain types of lung, liver, skin and soft tissue cancer.

Tecentriq Hybreza

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

Statement from the CEO: Halozyme

• We are delighted that Tecentriq Hybreza has been approved in the US 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.

Behind the FDA Approval

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.

About Halozyme

Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies.

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