The European Union has approved a subcutaneous version of Sarclisa (isatuximab) delivered through the CirCLIQ on-body injector, making it the first cancer therapy approved for wearable injector administration. The approval covers all of the drug’s existing EU indications for multiple myeloma, including newly diagnosed and relapsed or refractory disease.
The decision was based on results from the phase 3 IRAKLIA trial, which showed that the wearable injector was as effective as traditional intravenous (IV) infusions. The overall response rate was 71.1% with the injector compared with 70.5% with IV treatment. Infusion-related reactions were dramatically reduced, occurring in only 1.5% of patients versus 25% with IV administration.
The injector also offers major convenience benefits, reducing treatment time to about 13 minutes. Patient satisfaction was higher than with IV therapy, and most patients who tried both wearable and manual subcutaneous injections preferred the automated device