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FDA approves isatuximab subcutaneous formulation via OBI for multiple myeloma

On July 10, 2026, the US Food and Drug Administration (FDA) granted approval to the isatuximab subcutaneous (SC) formulation administered via on-body injector (OBI) in combination with standard-of-care (SoC) 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 induces anticancer activity by binding to CD38 targets on the myeloma cell and is well established in the myeloma treatment algorithm.2 Currently, isatuximab is approved in the US for combination therapy with various SoC regimens for relapsed/refractory (R/R) MM and in the frontline setting for newly diagnosed patients ineligible for autologous stem cell transplant.1  

Isatuximab is traditionally administered by IV infusion, a process which can be burdensome on both patients and healthcare professionals.2 The subcutaneous formulation, delivered via a wearable OBI, provides a more convenient alternative by automatically administering the treatment through a hidden, retractable needle.1

The FDA approval of the SC formulation of isatuximab is primarily 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) for 28-day cycles. All co-primary endpoints were met, establishing non-inferior efficacy for Isa OBI. The objective response rate (ORR) for Isa OBI was 71.1% compared to 70.5% with Isa IV, and the Ctrough geometric mean ratio was 1.532 (90% CI, 1.316 to 1.784), indicating preferable pharmacokinetics for Isa OBI.2  

Additionally, key secondary end points were also met, including comparable very good partial response (VGPR) rates of 46.4% for patients receiving Isa OBI and 45.9% for the Isa IV group (95% CI, 0.841 to 1.215).2 Notably, a preferable safety profile was observed in patients receiving Isa OBI, with lower infusion reaction incidence rates (1.5% and 25.0%, respectively). Furthermore, injection site reactions only occurred in 0.4% of injections with Isa OBI, and all reactions were mild.2   

At EHA 2026, we spoke with Xavier Leleu, MD, PhD, Poitiers University Hospital, Poitiers, France, who provided his thoughts on how the novel isatuximab SC formulation may positively impact patients and healthcare teams. Prof. Leleu stated, “Practically, what does that mean? It means that I believe Isatuximab with the OBI can be given at home. It means that you need to train and educate the patient initially. But thereafter, I’m pretty sure most of my patients can manage that on their own. No nurse, no pharmacist, no team in trouble because too many patients, too much work, and probably, I hope, a decrease in cost in the end.”

The FDA approval of the isatuximab SC formulation via OBI means the introduction of the first anti-CD38 therapy option available through both IV and SC administration. This new therapy may provide patients with a safer and more convenient administration method for isatuximab, and will help to improve patient satisfaction and reduce the strain on myeloma healthcare teams.1

References

  1. Sanofi. Press Release: Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector. Available here. (Last accessed 20/07/2026).
  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.

Written by Clare Harris

Edited by Anya Dragojlovic Kerkache