Safety, Reliability of SC Isatuximab via OBI in Multiple Myeloma Support Recent EU Approval: Xavier Leleu, MD, PhD

Earlier this week, on June 8, the European Commission approved subcutaneous isatuximab (Sarclisa; Sanofi), administered via the CirCLIQ on-body injector (OBI), for use across the European Union (EU) in combination with standard-of-care regimens for patients with multiple myeloma in all existing indications for intravenous (IV) isatuximab.

The approval was supported by data from the phase 3 IRAKLIA (NCT05405166) and the phase 2 IZALCO (NCT05704049) trials. Comprehensive data were published in the cross-trial analysis, "Safety and Reliability of Isatuximab Subcutaneous On-Body Injector: Results Across the Phase 3 IRAKLIA, Phase 2 IZALCO, and Phase 1B TCD15484 Trials," which was published in conjunction with the European Hematology Association 2026 Congress abstract release.

At the meeting, The American Journal of Managed Care^® spoke with Xavier Leleu, MD, PhD, lead IRAKLIA investigator and lead author of the cross-trial analysis, about the significance of the EU approval and the treatment’s demonstrated safety and reliability.

The first injection of anti-CD38 therapy carries the highest risk of infusion-related reactions (IRRs) and has traditionally required prolonged post-administration monitoring. With IV isatuximab, Leleu highlighted that IRRs occur in more than 25% of patients, whereas manual push subcutaneous (SC) formulations reduce that to 5% to 10%.

In the pooled analysis of 349 patients and 6426 injections, the OBI reduced the IRR rate to less than 1%. Nearly all IRRs were grade 1, with only a single grade 3 event; no reactions led to treatment discontinuation. According to Leleu, an IRR rate this low could make same-day outpatient discharge feasible beginning with the first dose and positions the OBI as a viable candidate for home administration.

In addition, device performance was near-perfect, with 99.9% of injections completed without interruption. Consequently, Leleu emphasized the OBI's potential to alleviate workforce pressures in oncology centers. While manual-push SC formulations improve patient convenience, they leave nursing and pharmacy workloads unchanged.

In contrast, the OBI operates autonomously once applied, eliminating bedside nursing time. The vial also connects directly to the device without reconstitution, reducing pharmacy preparation demands. With appropriate training, Leleu said patients could ultimately self-administer treatment at home, further easing pressure on oncology centers.

“This is where I see the real progress: its convenience for the patients to the utmost detail, plus for the team,” Leleu concluded.