FDA approves SC isatuximab via on-body injector for MM

On July 9, 2026, the U.S. Food and Drug Administration (FDA) approved subcutaneous (SC) isatuximab administered via an on-body injector (OBI), in combination with approved standard-of-care (SoC) regimens, for the treatment of multiple myeloma (MM), extending approval to all indications currently approved for intravenous (IV) isatuximab. Approved combinations include isatuximab + pomalidomide + dexamethasone in patients with ≥1 prior line of therapy (LoT) including lenalidomide and a proteasome inhibitor (PI); isatuximab + carfilzomib + dexamethasone after 1–3 prior LoT for relapsed/refractory MM; and isatuximab + bortezomib + lenalidomide + dexamethasone for patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT). SC isatuximab delivered via an OBI was approved in the European Union (EU), extending to all approved indications for the IV formulation, on June 8, 2026. 

The approval was supported by data from the phase III IRAKLIA trial (NCT05405166), which enrolled adults with RRMM after ≥1 prior LoT. Patients were randomized 1:1 to SC isatuximab 1,400 mg (n = 263) or IV isatuximab 10 mg/kg (n = 268), each with pomalidomide + dexamethasone, on Days 1, 8, 15, and 22 of Cycle 1 and Days 1 and 15 thereafter. The overall response rate (ORR) was 71.1% with SC isatuximab vs 70.5% with IV isatuximab (relative risk [RR], 1.008; 95% confidence interval [CI], 0.903–1.126; p = 0.0006), while Cycle 6 Day 1 steady-state trough concentration was noninferior with SC isatuximab (geometric mean ratio [GMR], 1.532; 90% CI, 1.316–1.784). Infusion-related reactions (IRRs) occurred in 1.5% of patients in the SC arm vs 25.0% in the IV arm (RR, 0.061; 95% CI, 0.022–0.164), while Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 81.7% vs 76.1%, respectively.