Halozyme Announces FDA Approval of Tecentriq Hybreza™ With ENHANZE® for Various Cancers
Friday, September 13, 2024
Halozyme Therapeutics, Inc. has confirmed that Roche has received approval from the U.S. Food and Drug Administration (FDA) for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs), incorporating Halozyme's ENHANZE® drug delivery technology.
Tecentriq Hybreza™ combines atezolizumab, a monoclonal antibody that targets PD-(L)1 to prevent cancer immune evasion, with Halozyme's recombinant human hyaluronidase enzyme, rHuPH20, to facilitate subcutaneous delivery.
This new formulation allows Tecentriq Hybreza™ to be administered subcutaneously in around seven minutes, compared to the 30-60 minutes typically required for intravenous (IV) infusion of Tecentriq® (atezolizumab). The treatment will be available across the U.S. for all adult indications previously approved for intravenous Tecentriq®, which include certain lung, liver, skin, and soft tissue cancers.
The FDA's decision was based on data from Roche's Phase IB/III IMscin001 study, which demonstrated similar blood levels of Tecentriq® when delivered subcutaneously, alongside a comparable safety and efficacy profile to the IV formulation.
Source: prnewswire.com
