FDA approves subcutaneous Sarclisa Escena with on-body injector for multiple myeloma

The FDA approved subcutaneous Sarclisa Escena on July 10, 2026, Sanofi announced. The approval covers isatuximab-irfc in combination with standard-of-care regimens for multiple myeloma across all existing indications of the intravenous formulation.¹

With this approval, Sarclisa Escena becomes the first anticancer treatment administered through both an on-body injector and manual subcutaneous administration.¹

The approval rested on data from multiple studies, most notably the pivotal phase 3 IRAKLIA trial. In that study, Sarclisa administered subcutaneously via the on-body injector combined with pomalidomide and dexamethasone produced a 71.1% objective response rate (187/263), compared with 70.5% (189/268) for the intravenous combination, meeting the non-inferiority criteria with a relative risk of 1.008 (95% CI: 0.903-1.126) in patients with relapsed or refractory disease who had received at least one prior line of treatment.¹

On safety, 25% of patients on the intravenous regimen experienced systemic administration reactions versus 1.5% on the subcutaneous regimen.¹ Injection site reactions occurred in 0.4% of injector uses (19 of 5,145 injections), with nearly all cases graded 1 except for one grade 2 event.¹ The most common adverse reactions occurring in at least 20% of patients were upper respiratory tract infection, fatigue, pneumonia, musculoskeletal pain, and diarrhea, while common hematology abnormalities at or above 40% included decreases in leukocytes, neutrophils, lymphocytes, platelets, and hemoglobin.¹

The studies used Enable Injections' hands-free on-body injector, which delivers high-volume subcutaneous medicines via a retractable 30-gauge needle.¹ The device is already approved for manual injection in Japan, where a separate regulatory submission for the on-body injector is under review.¹