The U.S. Food and Drug Administration (FDA) has approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech), the first and only PD-(L)1 inhibitor for subcutaneous (SC) injection, for all patients with IV indications for Tecentriq, including those with certain types of skin, lung, liver, and soft tissue cancer.
Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard IV infusion of Tecentriq (atezolizumab). Tecentriq Hybreza combines Tecentriq with Halozyme Therapeutics’ Enhanze drug delivery technology.
The FDA approval is based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. The Phase II IMscin002 study showed that 71% of patients preferred Tecentriq Hybreza over intravenous atezolizumab, and the most common reasons were less time in the clinic, increased comfort during treatment and reduced emotional distress. Four out of five patients (79%) chose Tecentriq Hybreza to continue their treatment, after experiencing both formulations.
The subcutaneous formulation of Tecentriq received its first worldwide approval in Great Britain in August 2023 and is now approved in more than 50 countries (outside the U.S. marketed as Tecentriq SC). Regulatory reviews in other countries and regions are ongoing.
