Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs), the first subcutaneous (SC) PD-(L)1 inhibitor for cancer treatment in the United States. This new formulation can be administered via a quick, seven-minute injection under the skin, compared to the traditional 30-60 minute intravenous (IV) infusion of Tecentriq (atezolizumab). Tecentriq Hybreza will be available for all approved adult IV indications in the U.S., including specific types of lung, liver, skin, and soft tissue cancers.
“By offering a subcutaneous version of this cancer immunotherapy, Tecentriq Hybreza gives patients and their healthcare providers more flexibility in treatment administration,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This new formulation builds on the proven safety and efficacy of the IV version of Tecentriq, allowing for faster treatment in more convenient settings.”
Ann Fish-Steagall, RN, senior vice president of Patient Services at the LUNGevity Foundation, added, “This approval offers a significant improvement in the patient experience. Giving patients more options empowers them to be active participants in their care, choosing the treatment method that best suits their needs.”
The FDA’s decision is based on data from the Phase IB/III IMscin001 study, which showed that the subcutaneous version of Tecentriq delivered comparable levels of the drug in the bloodstream and maintained a similar safety and efficacy profile to the IV formulation. Additionally, the Phase II IMscin002 study found that 71% of patients preferred Tecentriq Hybreza over the IV version, citing reasons such as less time spent in the clinic, greater comfort, and reduced emotional distress. Following trials of both formulations, 79% of patients opted to continue their treatment with Tecentriq Hybreza.
This development aligns with Roche’s commitment to improving the patient experience across its therapies. Tecentriq Hybreza joins Roche’s portfolio of 13 other subcutaneous treatments, offering patients more administration options based on their preferences.
Tecentriq’s subcutaneous formulation received its first approval in Great Britain in August 2023 and is now approved in 50 countries under the name Tecentriq SC. Regulatory reviews in other regions are ongoing.
