PARIS, France, June 8, 2026
Sanofi announced that the European Commission has approved Sarclisa® (isatuximab) subcutaneous (SC) for the treatment of patients with multiple myeloma (MM) across all currently approved indications of the intravenous formulation in the European Union. The approval marks a major milestone for cancer care, making Sarclisa the first anticancer therapy in Europe administered through an on-body injector (OBI). The therapy can be delivered either in outpatient settings or at home, offering patients and healthcare providers greater flexibility and convenience while maintaining the established efficacy and safety profile of Sarclisa.
First Anticancer Therapy Approved with On-Body Injector Technology
The newly approved subcutaneous formulation utilizes Enable Injections’ CirCLIQ® On-Body Injector, developed using the enFuse® platform, allowing automated delivery of Sarclisa through a wearable device. This innovative administration method is designed to reduce treatment burden for patients who often require long-term and repeated therapy sessions. Unlike conventional infusion approaches, the OBI system enables hands-free administration through a hidden retractable needle and supports treatment delivery outside traditional hospital environments. Sarclisa is now the first anti-CD38 monoclonal antibody available in Europe with both subcutaneous OBI and manual injection options, providing increased treatment flexibility for patients living with multiple myeloma.
Phase 3 IRAKLIA Trial Demonstrated Comparable Efficacy
The European approval is supported by results from the pivotal Phase 3 IRAKLIA study, which evaluated Sarclisa SC administered via OBI compared with intravenous Sarclisa in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. The trial met its primary objectives, demonstrating non-inferior efficacy between the subcutaneous and intravenous formulations. Patients receiving Sarclisa SC achieved an objective response rate of 71.1%, compared with 70.5% for the IV formulation. The study also confirmed comparable pharmacokinetic exposure and maintained the well-established safety profile of the therapy. Importantly, systemic infusion-related reactions were substantially lower in the SC group, occurring in only 1.5% of patients compared with 25% in the intravenous treatment group.
Advertisement
Improved Patient Experience and Treatment Convenience
Additional evidence from the Phase 2 IZALCO study highlighted strong patient preference for the on-body injector. Among participants who experienced both administration methods, 74.5% preferred the OBI system, while only 17% favored manual injection. Patient satisfaction was also significantly higher with Sarclisa SC delivered through the wearable device compared with intravenous administration. The studies suggest that OBI-based treatment can improve convenience, reduce time spent in healthcare facilities, and support broader access to therapy through home administration where permitted. In countries allowing home use, treatment duration remained consistent at approximately 13 minutes, with no new safety concerns observed.
Expanding Access Across the Multiple Myeloma Treatment Continuum
Since its launch in 2020, Sarclisa has been prescribed to nearly 70,000 patients worldwide and is approved in almost 60 countries. The therapy is currently authorized across multiple treatment settings, including newly diagnosed and relapsed or refractory multiple myeloma. The latest approval strengthens Sanofi’s oncology portfolio by combining proven clinical efficacy with a patient-centered delivery approach. Regulatory submissions for Sarclisa SC are also under review in several major markets, including the United States, China, and Japan, potentially expanding global access to the first oncology therapy administered through an on-body injector.
Source: Sanofi press release
