The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is recommending the approval of Sarclisa (isatuximab) as a subcutaneous formulation administered via on-body injector for myeloma patients.
On Friday, March 27, Sanofi announced via press release that "the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa (isatuximab) subcutaneous (SC) in combination with approved standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all currently approved indications for Sarclisa intravenous (IV) formulation in the EU."
According to Sanofi, "[the] recommendation [was] based on positive results demonstrating comparable efficacy, pharmacokinetics, and safety of Sarclisa regimens administered subcutaneously compared to intravenous infusion."
"If approved, Sarclisa would be the first available anticancer treatment to be administered through both an on-body injector (OBI) and manual injection, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both an OBI and manual injection. A final decision is expected in the coming months," Sanofi further stated.
The CHMP’s positive opinion is based mainly on the phase 3 IRAKLIA study (NCT05405166) in patients with relapsed or refractory multiple myeloma (RRMM). This study showed that the subcutaneous form of Sarclisa (isatuximab) worked just as well as the traditional intravenous (IV) form (non-inferior), with a similar safety profile.
Other studies that supported the recommendation include:
• Phase 3 GMMG-HD8 (NCT05804032) in newly diagnosed (NDMM), transplant-eligible
• Phase 2 IZALCO (NCT05704049) in RRMM
• Phase 2 ISASOCUT (NCT05889221) in transplant-ineligible NDMM
• A phase 1b study (NCT04045795) in heavily pretreated RRMM patients
Across these studies, patients using SC Sarclisa with an on-body injector (OBI) reported higher satisfaction and preference compared to IV infusions and manual injections, based on questionnaire results from both patients and healthcare providers.
Overall, these results suggest that SC Sarclisa with OBI could offer a more convenient and patient-friendly option while maintaining its proven effectiveness and safety in both newly diagnosed and relapsed multiple myeloma.
Sarclisa (isatuximab) IV is currently approved in the European Union (EU) for four uses in multiple myeloma, including transplant-ineligible NDMM; transplant-eligible NDMM; and for patients at first relapse (RRMM).
A regulatory application is also under review with the U.S. Food and Drug Administration (FDA).
The subcutaneous (SC) version of Sarclisa, given either with an on-body injector (OBI) or manual injection, is still being studied in clinical trials. Its safety and effectiveness have not yet been confirmed or approved by any regulatory authority.
Reference:
Sanofi’s Sarclisa subcutaneous formulation administered via on-body injector recommended for EU approval by the CHMP to treat multiple myeloma. Sanofi press release. March 27, 2026.
Sarclisa (isatuximab). European Medicines Agency.