Roche’s subsidiary Genentech has received the US Food and Drug Administration (FDA) approval for Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), for subcutaneous (SC) administration.
Tecentriq Hybreza combines Roche’s PD-L1 targeting monoclonal antibody Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology.
The cancer drug is now authorised in the US for all intravenous (IV) indications of Tecentriq (atezolizumab), including lung, liver, skin, and soft tissue cancers.
The SC injection option reduces treatment time to around seven minutes, compared with 30-60 minutes for a standard IV infusion of Tecentriq (atezolizumab).
Tecentriq Hybreza is the first and only PD-(L)1 inhibitor for subcutaneous, under-the-skin injection for patients in the US, according to the biotechnology company.
Genentech chief medical officer and global product development head Levi Garraway said: “Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration.
“We are pleased to introduce this new subcutaneous formulation that builds on the established safety and efficacy profile of intravenous Tecentriq and can treat patients faster and in more accessible settings.”
The FDA approval is based on data from the Phase 1B/3 IMscin001 study, evaluating the pharmacokinetics, safety, and efficacy of Tecentriq Hybreza, compared with IV Tecentriq.
The study enrolled 371 patients and met its primary endpoints of comparable levels of Tecentriq in the blood based on established pharmacokinetic measurements.
The FDA approval is also supported by the Phase 2 IMscin002 study, which met its primary endpoint, and confirmed that switching between Tecentriq Hybreza and IV Tecentriq was well tolerated.
Furthermore, the SC formulation of Tecentriq is now approved in more than 50 countries, with regulatory reviews underway in other countries and regions, said Genentech.
