Roche (SWX: ROG; OTCMKTS: RHHBY) , a leading Swiss pharmaceutical company, has secured US Food and Drug Administration (FDA) approval for its subcutaneous formulation of the programmed death-ligand 1 (PD-L1) inhibitor, Tecentriq Hybreza (atezolizumab, hyaluronidase). This new formulation has been approved for all 12 adult indications of intravenous Tecentriq, covering a range of cancers including lung, liver, skin, and soft tissue malignancies.
Utilizing Halozyme Therapeutics’ Enhanze drug delivery technology, an enzyme that facilitates the subcutaneous administration of drugs and fluids, Tecentriq Hybreza can be administered via subcutaneous injection in approximately 7 minutes, significantly reducing the time and healthcare practitioner supervision required for the traditional 30-60 minutes intravenous infusion.
Roche has highlighted this approval as a milestone, positioning Tecentriq Hybreza as the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy in the US market. However, it’s worth noting that while this is unique in the US, envafolimab, co-developed by China-based Alphamab and Tracon Pharmaceutical, is an anti-PD-L1 inhibitor that has been approved in China since 2020 for subcutaneous administration to treat adult patients with previously-treated microsatellite instability-high (MSI-H) or deficient MisMatch Repair (dMMR) advanced solid tumors. -Fineline Info & Tech
