Roche’s injectable PD-L1 inhibitor Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) has been approved by the US Food and Drug Administration (FDA) for multiple cancer types.
The subcutaneous (SC) formulation, which combines Tecentriq (atezolizumab) with Halozyme Therapeutics’ Enhanze drug delivery technology, can be injected over approximately seven minutes, compared to 30 to 60 minutes for a standard intravenous (IV) infusion of the drug.
The approval makes Tecentriq Hybreza the first and only SC anti-PD-L1 cancer immunotherapy for patients in the US and applies to all adult indications in which the drug’s IV form has previously been approved, including certain types of lung, liver, skin and soft tissue cancer.
The regulator’s decision was supported by results from the phase 1b/3 IMscin001 study, which demonstrated comparable levels of Tecentriq in the blood when administered subcutaneously, as well as a safety and efficacy profile consistent with the IV formulation.
Results also showed that 71% of patients preferred Tecentriq Hybreza over IV Tecentriq, citing reasons such as less time in the clinic, increased comfort during treatment and reduced emotional distress.
Levi Garraway, Roche’s chief medical officer and head of global product development, said: “By enabling SC administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration.
“We are pleased to introduce this new SC formulation that builds on the established safety and efficacy profile of IV Tecentriq and can treat patients faster and in more accessible settings.”
The US authorisation comes just over a year after NHS England announced that it would be the first health system in the world to roll out Tecentriq SC to eligible patients, after receiving approval from the Medicines and Healthcare products Regulatory Agency.
The SC form has since been approved in more than 50 countries, with regulatory reviews in other countries and regions currently ongoing.
Ann Fish-Steagall, senior vice president of patient services at the LUNGevity Foundation, said the latest approval “represents a significant option to improve the patient experience”, adding that “when patients have options, they feel empowered to be vital participants in their own care and choose their preferred treatment option”.