FDA Approves Roche’s Tecentriq Hybreza: First Subcutaneous PD-L1 Cancer Immunotherapy

Approval Date:
The FDA approved Tecentriq Hybreza on September 13, 2024.

First Subcutaneous PD-L1 Inhibitor:
Tecentriq Hybreza is the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy approved in the United States.

Administration Time:
The subcutaneous formulation reduces treatment time to approximately 7 minutes, compared to 30-60 minutes for intravenous (IV) infusion.

Indications:
Tecentriq Hybreza is approved for all IV indications of Tecentriq in adults, including certain types of lung, liver, skin, and soft tissue cancer.

Clinical Trials:
The approval is based on data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood and a consistent safety and efficacy profile with the IV formulation.

Patient Preference:
The Phase II IMscin002 study demonstrated a strong patient preference for Tecentriq Hybreza over IV atezolizumab, with 71% of patients favoring the subcutaneous option due to reduced clinic time, increased comfort, and less emotional distress.

Global Availability:
Tecentriq Hybreza has been approved in over 50 countries, including the UK, where it was first approved last year.