The subcutaneous anti-PD-L1 cancer immunotherapy atezolizumab (brand name Tecentriq subcutaneous (SC)) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), paving the way for its use in the NHS in England, its manufacturer Roche has announced.
Offering patients a faster and more convenient treatment option, the SC injection is administered under the skin and takes seven minutes to complete – 75% quicker than the 30-60 minute duration of the IV infusion.
The MHRA approval covers all indications in which the intravenous (IV) form of atezolizumab has previously been approved, including certain types of bladder, breast, liver and lung cancer.
The NHS in England is to become the first health system in the world to roll out the injection, and hundreds of eligible patients being treated with IV atezolizumab will be switched onto the SC version ‘within weeks’, the NHS has confirmed.
It is anticipated that the majority of the approximately 3,600 patients starting treatment of atezolizumab annually in England will switch onto the SC injection. However, where patients are receiving intravenous chemotherapy in combination with atezolizumab, they may remain on the transfusion.
Professor Peter Johnson, NHS national director for cancer, said: ‘The world-first introduction of this treatment will mean that hundreds of patients can spend less time at the hospital and will free up valuable time in NHS chemotherapy units.
‘Maintaining the best possible quality of life for cancer patients is vital, so the introduction of faster under-the-skin injections will make an important difference.’
The Tecentriq SC marketing authorisation application is currently under assessment by the European Medicines Agency (EMA). Evaluations by the US Food and Drug Administration (FDA) and other health authorities globally are also ongoing.
Levi Garraway, chief medical officer and head of global product development at Roche, added: ‘Cancer immunotherapy has transformed the way we treat cancer. Giving Tecentriq subcutaneously now offers patients a faster and more flexible treatment option and can free up resources for healthcare systems, while maintaining its established safety profile.
‘We are working with health authorities globally to bring this option to many more patients around the world.’
Atezolizumab IMscin001 study results
The MHRA approval is based on pivotal data from the global phase 1b/3 IMscin001 study, which evaluated the pharmacokinetics, safety and efficacy of atezolizumab SC, compared with atezolizumab IV in 371 patients with previously treated locally advanced or metastatic NSCLC for whom prior platinum therapy has failed.
The study showed comparable levels of atezolizumab in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.
While the IMscin001 trial was conducted within the hospital setting, Roche has said that SC atezolizumab may also be suitable for out-of-hospital administration by a healthcare professional.
Commenting on the approval, Dr Alexander Martin, consultant oncologist at West Suffolk NHS Foundation Trust, said: ‘This is great news for both patients and clinicians. We welcome any new initiative that brings speedier treatment to patients and gives them more comfortable care.
‘This approval will not only allow us to deliver convenient and faster care for our patients, but will enable our teams to treat more patients throughout the day.’
The faster treatment comes at no extra cost to the NHS thanks to the existing commercial deal negotiated between NHS England and the manufacturer Roche.