FDA Approves Roche's Tecentriq Hybreza, a Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy
核心洞察
The FDA has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) as the first subcutaneous PD-(L)1 (搜索) inhibitor for cancer immunotherapy.
Tecentriq Hybreza offers a faster administration time of approximately seven minutes compared to the 30-60 minutes required for intravenous Tecentriq.
This subcutaneous formulation maintains the established safety and efficacy profile of intravenous Tecentriq across its approved indications.
The U.S. Food and Drug Administration (FDA) has approved Roche's Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), marking the first subcutaneous (SC) PD-(L)1 (搜索) inhibitor for cancer immunotherapy. This new formulation offers a more convenient and faster administration option for patients across various cancer types.
Tecentriq Hybreza is administered subcutaneously via injection in approximately seven minutes, significantly reducing the administration time compared to the 30-60 minutes required for the standard intravenous (IV) infusion of Tecentriq (atezolizumab). The approval covers all IV indications of Tecentriq approved for adults in the U.S., including specific types of lung, liver, skin, and soft tissue cancers.
Clinical Impact and Patient Experience
According to Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, Tecentriq Hybreza provides patients and physicians with greater flexibility and choice of treatment administration. The subcutaneous formulation builds upon the established safety and efficacy profile of intravenous Tecentriq while offering a faster and more accessible treatment option.
Ann Fish-Steagall, RN, senior vice president of Patient Services at the LUNGevity Foundation, emphasized the importance of patient choice, stating, "When patients have options, they feel empowered to be vital participants in their own care and choose their preferred treatment option."
Global Availability and Regulatory Status
The subcutaneous formulation of Tecentriq received its first worldwide approval in Great Britain in August 2023 and is now approved in 50 countries (marketed as Tecentriq SC outside the U.S.). Regulatory reviews are ongoing in other countries and regions.