Sanofi's Sarclisa Becomes First FDA-Approved Anticancer Treatment Delivered via On-Body Injector

The FDA has approved subcutaneous isatuximab-irfc (Sarclisa Escena), administered in combination with standard-of-care regimens, for multiple myeloma (MM) across all indications previously approved for the intravenous formulation.¹ The approval makes Sarclisa Escena the first anticancer treatment in the US to be administered through both an on-body injector (OBI) and manual subcutaneous injection, giving physicians and patients a choice between the two delivery methods.¹ Isatuximab is a monoclonal antibody that targets CD38, a protein highly expressed on multiple myeloma cells, and has now been approved in nearly 60 countries across four indications spanning newly diagnosed and relapsed or refractory MM.¹

What clinical data supported the approval?

The approval was supported by the pivotal Phase III IRAKLIA study, a randomized, open-label trial that enrolled 531 patients with relapsed or refractory MM who had received at least one prior line of therapy. Patients were randomized 1:1 to receive Sarclisa either intravenously at 10 mg/kg or subcutaneously via OBI at a fixed 1,400 mg dose, both in combination with pomalidomide and dexamethasone.² The trial's coprimary endpoints were overall response rate and trough drug concentration, with secondary endpoints including very good partial response rate, infusion-reaction incidence, and patient satisfaction.² Results demonstrated that the subcutaneous OBI formulation achieved efficacy, pharmacokinetics, and safety comparable to the IV formulation, while significantly shortening treatment time and reducing infusion-related reactions.¹

Why does the delivery mechanism matter here?

Wearable, on-body injector technology has been gaining traction across the biologics field as a way to administer higher-volume formulations without the time and infrastructure burden of IV infusion. As Mike Hooven, CEO of Enable Injections, has explained regarding large-volume wearable injectors more broadly, these devices enable stress-free subcutaneous biologics delivery at home or work, and are expected to increase patient compliance and generate cost savings by reducing dependence on infusion-chair time and clinical staff involvement.³ For multiple myeloma specifically, a disease typically managed with repeated visits for infused combination regimens, moving isatuximab to a wearable subcutaneous format has the potential to meaningfully reduce the treatment burden associated with long-term MM management.

The US approval follows earlier regulatory wins for the same subcutaneous OBI formulation in the EU, where Sarclisa Escena became the first anticancer therapy administered via on-body injector in that market in June 2026, and in Japan, marking a broader global rollout of the delivery format across Sanofi's isatuximab franchise.⁴ Sarclisa-based regimens have now been prescribed to more than 70,000 patients worldwide.¹

What happens next?

With approval secured in the US, EU, and Japan, Sanofi's focus shifts to commercial rollout and physician/patient education on the new OBI administration option, alongside continued regulatory submissions the company has planned in additional markets.⁴ Because the approval spans all indications previously approved for the IV formulation rather than a single line of therapy, uptake will likely depend heavily on how quickly infusion centers and community oncology practices adopt the OBI workflow alongside existing IV infrastructure.

References

1. Sanofi's subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector. (2026 Jul 10). GlobeNewswire,
2. Conroy R. (2026 Apr 23). FDA Delays Decision on Subcutaneous Isatuximab in Multiple Myeloma. Cancer Network. https://www.cancernetwork.com/view/fda-delays-decision-on-subcutaneous-isatuximab-in-multiple-myeloma