Roche has received marketing authorisation from the European Commission (EC) for its immunotherapy Tecentriq SC (atezolizumab) for subcutaneous administration to treat cancers.
Tecentriq SC is the first programmed death ligand-1 cancer immunotherapy to be offered in the EU for subcutaneous dosing.
The new formulation is set to significantly reduce treatment time for patients, from the 30–60 minutes required for intravenous (IV) infusion to approximately seven minutes with the subcutaneous method.
The marketing authorisation is applicable for all existing indications approved in the EU for Tecentriq IV.
The EC’s decision is based on results from the randomised, multicentre Phase IB/III IMscin001 study that assessed the safety, efficacy and pharmacokinetics of Tecentriq SC versus Tecentriq IV.
The study enrolled 371 subjects with previously treated locally advanced or metastatic non-small cell lung cancer unresponsive to platinum therapy.
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Tecentriq SC demonstrated pharmacokinetics comparable with the IV formulation.
The trial confirmed similar levels of Tecentriq in the blood and a safety and efficacy profile in line with the IV version.
The study met its primary endpoints and showed equivalent efficacy between the subcutaneous and IV treatments, as evaluated by progression-free survival, overall response rate, overall survival and duration of response.
Following its initial approval in Britain in August 2023, Tecentriq SC’s indications mirror those of the IV formulation, providing a new, faster treatment option for cancer patients across the EU.
Roche Global Product Development head and chief medical officer Levi Garraway stated: “We are pleased to introduce the first subcutaneous PD-L1 cancer immunotherapy in Europe.
“Giving Tecentriq subcutaneously provides more flexibility to patients, while also helping to free up resources in constrained healthcare systems.”
The latest development comes after the company agreed to acquire US-based company Carmot Therapeutics for $2.7bn (SFr2.32bn).
Carmot and its employees will become part of the pharmaceuticals segment of Roche following the deal’s closure.
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