Roche announces that the European Commission has authorized the marketing of atezolizumab SC, the first anti-PD-L1 cancer immunotherapy for subcutaneous (under the skin) injection available in the European Union. In the last year – reports a note – over 38,000 people in the EU have received atezolizumab for the treatment of different types of lung, liver, bladder and breast cancer. So far, atezolizumab has been administered via IV infusion, which takes approximately 30 to 60 minutes. The new subcutaneous injection, approved for all indications of IV atezolizumab, will reduce treatment time to approximately 7 minutes, with most injections lasting between four and eight minutes.
“We are pleased to have obtained European authorization for the first anti-PD-L1 anti-tumor immunotherapy for subcutaneous use,” said Levi Garraway, MD, Ph.D., Chief Medical Officer and Head of Global Product Development at Roche. The administration of atezolizumab subcutaneously offers patients greater flexibility and helps generate resource savings for the benefit of public health systems.”
“Ensuring the best possible quality of life for people living with cancer is a priority – stated Dr. Enriqueta Felip, Head of the Thoracic Oncology Unit at the Vall d'Hebron Hospital in Barcelona – The availability of a anti-tumor immunotherapy option in subcutaneous formulation could make the difference for patients and their families, thanks to the opportunity to reduce administration time to a minimum and allow, where possible, treatment outside the hospital”.
The approval – details the note – is based on the registration data of the phase IB/III IMscin001 study, which highlighted a safety and efficacy profile in line with the IV formulation. 90% of healthcare workers interviewed during the study agreed that the SC formulation was easy to administer and 75% stated that this option could save time at the healthcare organization level compared to the IV formulation.
Silvia Novello, full professor of Medical Oncology, University of Turin, President of Walce Onlus, adds: “As Walce Onlus we are committed daily to supporting patients and their families to promote a better quality of life. It is therefore absolutely good news for us to learn of the approval of atezolizumab SC by the EMA. This type of administration will certainly be more appreciated by patients: switching from an intravenous administration to a subcutaneous injection certainly has a positive psychological impact as well as a gain in precious moments (from approximately 1 hour for the infusion to a few minutes for the injection ) for the patient and his caregiver. For healthcare personnel – he concludes – this will mean being able to reorganize day hospital activities, improve flows and, eventually, potentially reduce waiting lists for the provision of therapy”.
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