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FDA Approves Roche's Tecentriq Hybreza, First Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

NextEdge Admin

14 Sep 2024

1 min 53 sec

Roche announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs), the first PD-(L)1 inhibitor available as a subcutaneous (SC) injection for patients in the U.S. Tecentriq Hybreza can be administered under the skin in about seven minutes, compared to the 30-60 minutes needed for intravenous (IV) infusion of Tecentriq (atezolizumab). This new formulation is available for all IV-approved Tecentriq indications, including specific types of lung, liver, skin, and soft tissue cancers.

“Tecentriq Hybreza offers patients greater flexibility in cancer treatment administration,” said Dr. Levi Garraway, Roche’s Chief Medical Officer. He emphasized that this new formulation builds on the safety and efficacy of IV Tecentriq while offering faster and more convenient treatment.

The FDA's decision was based on data from the Phase IB/III IMscin001 study, which showed comparable drug levels and similar safety and efficacy between SC and IV forms. The Phase II IMscin002 study revealed that 71% of patients preferred the SC version due to less time in the clinic, greater comfort, and reduced emotional distress.

Tecentriq Hybreza has already been approved in 50 countries and continues to undergo regulatory reviews worldwide.