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EMA approves isatuximab subcutaneous formulation via OBI for patients with myeloma

On June 8, 2026, the European Medicines Agency (EMA) granted approval to isatuximab subcutaneous (SC) in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all currently approved indications for the isatuximab intravenous (IV) formulation.1

Isatuximab is an anti-CD38 monoclonal antibody that exerts anticancer activity by binding to CD38 on myeloma cells and has a well-established efficacy.1 Currently, isatuximab IV is approved in the EU for combination therapy with various standard-of-care regimens for transplant-ineligible newly diagnosed (ND) MM, transplant-eligible NDMM, and relapsed/refractory (R/R) MM.1

Isatuximab is primarily administered through IV infusion, which is time-consuming, requires large administration volumes, and can be uncomfortable for patients and strenuous for nurses.2,3 To address these limitations, the isatuximab SC formulation has been designed to be administered via an on-body-injector (OBI) to provide patients with a convenient alternative. The OBI is a wearable drug-delivery platform that automatically delivers isatuximab through a small, hidden, and retractable needle, significantly improving the patient experience.1

The approval of the SC formulation of isatuximab is supported by data from the randomized, open-label Phase III IRAKLIA (NCT05405166) trial, evaluating the efficacy and safety of isatuximab SC (Isa SC) versus isatuximab IV (Isa IV) administration in combination with pomalidomide and dexamethasone in patients with R/R MM following one prior line of therapy.2 531 patients were randomized in a 1:1 ratio to each group (OBI, n=263; IV, n=268) and were treated until progression, unacceptable toxicity, or patient request. After a median follow-up of 12 months, the objective response rate (ORR) for Isa OBI was 71.1% compared with 70.5% for Isa IV, and the C(trough) geometric mean ratio was 1.532 (90% CI, 1.316 to 1.784), indicating pharmacokinetic noninferiority between Isa OBI and IV.2 Safety results were also comparable between Isa OBI and Isa IV, observed by grade ≥3 treatment-emergent adverse event incidence rates of 81.7% and 76.1%, respectively. Notably, a preferable safety profile was observed in patients receiving Isa OBI, with a lower incidence of infusion reactions (1.5% versus 25.0%).

Further data from the randomized, sequential, open-label Phase II IZALCO (NCT05704049) trial confirmed a clear patient preference for isatuximab SC delivered via OBI over manual injection, with 74.5% of patients with R/R MM preferring the OBI formulation.

At the EHA 2026 Congress, we spoke with Enrique Ocio, MD, PhD, Marquis of Valdecilla University Hospital, Santander, Spain, who commented on the value of this novel isatuximab SC formulation. He stated, “The OBI for isatuximab is really a step forward in the administration of these new drugs… What we have here is that we have proof for isatuximab, a new device, which is really attractive because… You put the vial of the isatuximab inside the device to attach, it adheres, and you press a button – and it does everything on its own. It’s very convenient.”

The approval of the isatuxumab SC formulation via OBI marks the introduction of the first anticancer therapy option available through both an OBI and manual SC administration. This new approach may provide patients with a more convenient method of administering isatuximab, potentially reducing the strain on myeloma healthcare teams.1

References

  1. Sanofi. Press Release: Sanofi’s Sarclisa subcutaneous approved in the EU as the first anticancer treatment administered via an on-body injector. Available here. (Last Accessed 18/06/2026).
  2. Ailawadhi S, Špička I, Spencer A, et al. Isatuximab Subcutaneous by On-Body Injector Versus Isatuximab Intravenous Plus Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Phase III IRAKLIA Study. J Clin Oncol. 2025;43(22):2527-2537.
  3. Sánchez Avello N, Calvo Pajares P, Cordero P, et al. Subcutaneous administration of isatuximab in patients with multiple myeloma by an on-body delivery system: results of a nurse survey. Front Oncol. 2025 Jun 18;15:1547108.
  4. Parmar G, Capra M, Seguro F, et al. Efficacy and safety of isatuximab subcutaneous plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma: results of the Phase 2 study IZALCO. Blood Cancer J. 2025;16(1):16.

Written by Clare Harris

Edited by Anya Dragojlovic Kerkache