By VETTAPHARMA Reporter – Derek Roche: Sanofi announced that the European Commission has approved the subcutaneous (SC) formulation of Sarclisa (isatuximab) in combination with standard-of-care regimens for patients with multiple myeloma (MM) across all existing European Union indications currently approved for the intravenous (IV) formulation. The approval makes Sarclisa the first anticancer therapy in the European Union to be administered through an on-body injector (OBI) and the first multiple myeloma treatment available through both SC OBI and manual SC injection.
The newly approved SC formulation can be administered using Enable Injections’ CirCLIQ® OBI, providing flexibility for treatment delivery in outpatient clinics or at patients’ homes. The approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is supported primarily by results from the pivotal Phase 3 IRAKLIA study and additional supporting studies.
Sarclisa IV is currently approved in the EU across four multiple myeloma indications, including newly diagnosed transplant-ineligible and transplant-eligible patients in combination with bortezomib, lenalidomide and dexamethasone, as well as relapsed or refractory multiple myeloma in combination with pomalidomide and dexamethasone or carfilzomib and dexamethasone. The new approval extends these indications to the SC formulation.
The Phase 3 IRAKLIA study demonstrated non-inferiority of Sarclisa SC administered via OBI compared with IV administration in relapsed or refractory multiple myeloma patients who had received at least one prior line of treatment. The objective response rate was 71.1% with Sarclisa SC plus pomalidomide and dexamethasone compared with 70.5% for Sarclisa IV plus pomalidomide and dexamethasone, meeting the study’s non-inferiority endpoint (risk ratio 1.008; 95% confidence interval 0.903-1.126; p=0.0006).
Patient experience data favored the SC OBI approach. In IRAKLIA, 70% of patients receiving Sarclisa SC via OBI reported being satisfied or very satisfied with treatment administration compared with 53.4% of patients receiving IV therapy (odds ratio 2.036; 95% CI 1.425-2.908; p=0.0001). In the Phase 2 IZALCO study, 74.5% of patients preferred OBI administration after experiencing both delivery methods, compared with 17% who preferred manual SC injection and 8.5% who had no preference.
The safety profile of Sarclisa SC was consistent with the established IV formulation. Systemic infusion reactions occurred in 1.5% of patients receiving Sarclisa SC compared with 25% of patients receiving IV treatment. Injection-site reactions were uncommon, occurring in 0.4% of OBI injections (19 events among 5,145 injections), with nearly all events classified as Grade 1.
Among patients eligible for home administration, the median injection duration was 13 minutes in both clinic and home settings. All home-administered injections were completed successfully, and no new safety signals were observed.
Sarclisa has been approved in nearly 60 countries across four multiple myeloma indications and has been prescribed to nearly 70,000 patients worldwide. Additional regulatory submissions for the SC formulation are currently under review in several markets, including the United States, China, and Japan.
Quick FAQs
1. What Is Sarclisa?
Sarclisa (isatuximab) is an anti-CD38 monoclonal antibody approved for the treatment of certain patients with newly diagnosed and relapsed/refractory multiple myeloma. It is approved in nearly 60 countries and has been prescribed to nearly 70,000 patients worldwide.
2. What Did The European Commission Approve?
The European Commission approved Sarclisa subcutaneous formulation, administered via an on-body injector or manual SC injection, across all existing EU indications currently approved for the IV formulation.
3. What Was The IRAKLIA Study?
IRAKLIA (NCT05405166) was a randomized, open-label Phase 3 study evaluating the non-inferiority of fixed-dose Sarclisa SC administered via OBI versus weight-based Sarclisa IV, both combined with pomalidomide and dexamethasone, in relapsed or refractory multiple myeloma patients who had received at least one prior therapy.
4. What Is Multiple Myeloma?
Multiple myeloma is a cancer of plasma cells that often requires prolonged and repeated treatment visits, creating a significant burden for patients and healthcare systems.
5. What Were The Key Results?
Sarclisa SC achieved a 71.1% objective response rate versus 70.5% with IV administration, demonstrated non-inferiority, reduced systemic infusion reactions to 1.5% versus 25%, and achieved higher patient satisfaction rates of 70% versus 53.4%.
6. Why Is This Important?
The approval introduces the first anticancer therapy delivered via an on-body injector in the EU, enabling home administration, reducing treatment burden, improving patient satisfaction, and expanding administration flexibility while maintaining established efficacy and safety.
