The European Commission has approved Sarclisa (isatuximab) subcutaneous as the first anticancer therapy in the EU to be administered via an on-body injector (OBI), marking a delivery milestone for multiple myeloma treatment. Sanofi’s approval covers the subcutaneous formulation across all four indications already held by the intravenous version, spanning newly diagnosed and relapsed/refractory multiple myeloma, and enables administration in both outpatient and home settings.
The subcutaneous formulation is delivered using the CirCLIQ OBI, developed by Cincinnati-based Enable Injections on its enFuse platform. The device uses a hidden retractable needle and automated injection mechanism, completing administration in a median of 13 minutes. Sarclisa SC is approved both via the OBI and by manual injection, making it the only anti-CD38 monoclonal antibody in the EU available through both delivery modes.
Isatuximab targets CD38, a glycoprotein highly expressed on myeloma cells, triggering direct tumor cell killing through multiple immune mechanisms including antibody-dependent cytotoxicity and complement-dependent cytotoxicity. The subcutaneous formulation delivers a fixed dose, replacing the weight-based intravenous dosing used previously.
The approval is supported primarily by the IRAKLIA Phase III study (NCT05405166), a randomized, open-label trial comparing Sarclisa SC via OBI with Sarclisa IV, each in combination with pomalidomide and dexamethasone, in adults with relapsed/refractory multiple myeloma who had received at least one prior line of therapy. The co-primary endpoints were objective response rate (ORR) and pre-dose plasma concentration at steady state. Sarclisa SC achieved an ORR of 71.1% versus 70.5% for IV, establishing non-inferiority (risk ratio 1.008; 95% CI: 0.903–1.126; p=0.0006). Systemic infusion reactions occurred in 1.5% of SC-treated patients compared with 25% in the IV arm, though low-grade injection site reactions were reported in 0.4% of OBI administrations.