SC isatuximab via on-body injector approved in EU for multiple myeloma

On June 8, 2026, subcutaneous (SC) isatuximab administered via an on-body injector (OBI) was approved in the European Union (EU) in combination with standard-of-care (SoC) regimens for patients with multiple myeloma (MM), extending authorization to all indications currently approved for intravenous (IV) isatuximab. IV isatuximab is currently approved in the EU in combination with bortezomib + lenalidomide + dexamethasone for transplant-ineligible (TI) and transplant-eligible (TE) newly diagnosed MM (NDMM), and in combination with pomalidomide + dexamethasone or carfilzomib + dexamethasone for relapsed/refractory MM (RRMM). This latest approval follows a March 2026 positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP). 

The approval was supported by data from the phase III IRAKLIA trial (NCT05405166), which evaluated SC isatuximab administered via an OBI + pomalidomide + dexamethasone (Pd) vs IV isatuximab + Pd in adult patients with RRMM who had received ≥1 prior line of therapy (LoT). The overall response rate (ORR) was 71.1% in patients receiving SC isatuximab via an OBI (n = 263) vs 70.5% in those receiving IV isatuximab (n = 268) (risk ratio [RR], 1.008; 95% confidence interval [CI], 0.903–1.126; p = 0.0006), meeting the prespecified non-inferiority criterion. The approval was also supported by data from the phase II IZALCO trial (NCT05704049), evaluating SC isatuximab via an OBI and manual injection in patients with RRMM.