First came the United Kingdom, and now the European Union is ready to join in the subcutaneous administration of the anticancer drug atezolizumab. In fact, the European Commission has just approved the marketing of the under-the-skin formulation of the monoclonal antibody used against various types of cancer. An important change of pace in the field of immunotherapies, because in this case the type of administration profoundly changes the burden of care for both patients and healthcare systems. For the better.
In this new guise – approved for all indications of the drug, used against liver, bladder, lung and breast cancer – it will be possible to reduce the time needed to receive therapy by approximately 80%. We go from half an hour, an hour sometimes required for the intravenous formulation, to just seven minutes on average needed for the subcutaneous one. The tests – aimed at comparing the new formulation with the traditional one – showed that it is possible to do so, without putting the safety and effectiveness of the antibody at risk. This is demonstrated by the data coming from the phase IB/III IMscin001 study, which compared the two formulations on a sample of 371 patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who had not responded to chemotherapy.
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The new formulation of atezolizumab
Unlike the intravenous formulation, in the subcutaneous one the monoclonal antibody – a form of immunotherapy that aims to awaken the action of T lymphocytes by inhibiting the PD-L1 protein – also contains an enzyme that degrades hyaluronic acid, which favors last the absorption of the drug into the blood. The news of the approval of the subcutaneous drug was greeted with enthusiasm by experts, as it was last summer following the green light in the United Kingdom. In fact, everyone has underlined how atezolizumab administered subcutaneously will save time and thus quality of life. A gain that also has repercussions on healthcare systems, allowing for more streamlined administration procedures, freer healthcare workers and a consequent saving of resources.
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Less time in hospital, shorter waiting lists
“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 for the patient and his caregiver – he commented Silvia Novello, full professor of Medical Oncology, University of Turin, President of WALCE Onlus – For healthcare personnel this will mean being able to reorganize the Day Hospital activity, improve flows and, eventually, potentially reduce waiting lists for provision of therapy”. Without considering, he added Enriqueta Feliphead of the thoracic oncology unit at the Vall d’Hebron Hospital in Barcelona and who took part in the studies on the new formulation, said that this could “allow, where possible, treatment outside the hospital”.
The arrival of the approval of the new formulation – the first subcutaneous cancer immunotherapy available in the EU – represents an important milestone in the field. Various teams have been working for some time to make the administration of anti-cancer immunotherapies easier, perhaps using, as in this case, subcutaneous administration instead of the more traditional (and much more expensive) intravenous infusions.