Subcutaneous atezolizumab (brand name Tecentriq SC) has been granted marketing authorisation by the European Commission (EC) for multiple cancer types, its manufacturer Roche has announced.
It is the first PD-(L)1 cancer immunotherapy for subcutaneous (SC) injection available in the European Union and offers the potential for a faster and more convenient alternative to intravenous (IV) infusion of atezolizumab.
The SC injection is administered under the skin and takes approximately seven minutes to complete, with most injections taking between four and eight minutes. This is 75% quicker than the 30-60 minute duration of the IV infusion.
The EC approval covers all indications in which the IV form of atezolizumab has previously been approved, including certain types of lung, liver, bladder and breast cancers.
In August 2023, the NHS in England became the first health system in the world to roll out SC atezolizumab after its approval by the Medicines and Healthcare products Regulatory Agency (MHRA).
The EC and MHRA approvals were based on pivotal data from the Phase IB/III IMscin001 study, which showed comparable levels of atezolizumab in the blood, when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.
Some 90% of healthcare professionals who were surveyed as part of the study agreed that the SC formulation is easy to administer and 75% said it could save time for healthcare teams compared with the IV formulation.
While the IMscin001 trial was conducted within the hospital setting, SC atezolizumab may be administered by a healthcare professional outside of the hospital in a community care setting or at a patient’s home, depending on national regulations and health systems.
Commenting on the approval, Dr Enriqueta Felip, head of the Thoracic Cancer Unit of Vall d’Hebron Hospital in Barcelona, Spain, said: ‘Ensuring the best possible quality of life is crucial for people living with cancer.
‘The availability of a subcutaneous cancer immunotherapy option that can minimise the time receiving treatment and even allow for treatment outside of a hospital will undoubtedly make a significant difference to patients and their loved ones.’
Levi Garraway, Roche’s chief medical officer and head of global product development, added: ‘Giving Tecentriq subcutaneously provides more flexibility to patients, while also helping to free up resources in constrained healthcare systems.’
Roche is working with national health systems in Europe to ensure patients can access SC atezolizumab as quickly as possible, and the company is also in discussion with several providers in Europe to include the drug in cancer homecare initiatives where possible.