Roche snags FDA nod for subcutaneous cancer immunotherapy

Sept. 13, 2024

The FDA approved Roche's Tecentriq Hybreza, the first subcutaneous anti-PD-(L)1 cancer immunotherapy.

The drug is a combination of atezolizumab and hyaluronidase, and allows for subcutaneous injections in approximately seven minutes, significantly reducing treatment time compared to the 30-60 minute intravenous (IV) infusion. The new option is available for all IV Tecentriq indications approved for adults, including specific cancers of the lung, liver, and skin.

The approval was supported by clinical studies demonstrating that Tecentriq Hybreza’s efficacy and safety are consistent with the IV version. The IMscin001 study showed comparable levels of the drug in the blood for both delivery methods, while patient preference data from the IMscin002 trial indicated that 71% of participants favored the subcutaneous formulation over the IV option, citing shorter treatment times and improved comfort.

Tecentriq Hybreza aims to improve the patient experience by offering a faster, less invasive treatment option. This subcutaneous version builds on Tecentriq's established use in treating various cancers, providing greater flexibility in how care is administered.