Sarclisa (isatuximab) SC — the first anticancer therapy approved by the European Union (EU) to be administered through an on-body injector (OBI) — "can provide the flexibility of administration at patients’ homes and in the outpatient setting."

On Monday, June 8, Sanofi announced in a press release that “the European Commission has approved Sarclisa (isatuximab) subcutaneous (SC) in combination with standard-of-care regimens for the treatment of patients with multiple myeloma across all existing indications for Sarclisa intravenous (IV) formulation.”

“Sarclisa is the first anticancer therapy in the European Union (EU) to be administered through an on-body injector (OBI) and manual SC administration and can provide the flexibility of administration at patients’ homes and in the outpatient setting,” stated Sanofi.

Administered via the CirCLIQ® OBI, isatuximab “offers a treatment experience designed around the needs of patients and HCPs and enables flexible administration in either home or outpatient settings,” Sanofi further added.

According to Mohamad Mohty, MD, PhD — International Myeloma Working Group (IMWG) Member, Professor of Hematology at the Sorbonne University, and Head of the Clinical Hematology and Cellular Therapy Department at the Saint-Antoine Hospital, Paris, France — “the ability to administer a therapy through an on-body injector, particularly an anti-CD38 monoclonal antibody with well-established efficacy, either in the clinic or at home represents a meaningful step forward. With this new option now approved, we have an opportunity to reduce pressure on healthcare systems while placing greater flexibility and convenience at the heart of patient-centered care.”

Since its launch in 2020, isatuximab has been approved in the EU across four indications in myeloma. The IV formulation is approved in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for both transplant-ineligible and transplant-eligible newly diagnosed multiple myeloma (NDMM), as well as with pomalidomide and dexamethasone (Pd) or carfilzomib and dexamethasone (Kd) for relapsed/refractory myeloma (RRMM).

Approval of the subcutaneous (SC) formulation was supported by results from the pivotal phase 3 IRAKLIA study and additional clinical studies. In IRAKLIA, isatuximab SC demonstrated non-inferior efficacy compared with the IV formulation in patients with RRMM. The approval followed a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The phase 3 IRAKLIA and phase 2 IZALCO studies evaluated the SC administration of isatuximab using an OBI. In IRAKLIA, 70% of patients receiving isatuximab SC via OBI reported being satisfied or very satisfied with treatment administration, compared with 53.4% of patients receiving intravenous (IV) isatuximab, while IZALCO found that 74.5% of patients preferred OBI administration over manual injection and 8.5% preferred manual injection. The OBI, Enable Injections’ enFuse-powered CirCLIQ® device, delivers isatuximab SC through a hidden, retractable needle and is designed for use in outpatient or home settings.

In IRAKLIA, isatuximab SC administered via OBI in combination with pomalidomide and dexamethasone (Pd) achieved an objective response rate (ORR) of 71.3%, compared with 70.5% for IV Sarclisa-Pd, meeting the predefined criterion for non-inferiority in adults with RRMM who had received at least one prior line of therapy. The safety profile of isatuximab SC-Pd was generally consistent with that of IV Isa-Pd, with systemic infusion reactions occurring in 1.5% of patients receiving SC treatment versus 25% with IV treatment. No new safety signals were identified, although low-grade injection-site reactions occurred in 1.4% of OBI injections and were mostly grade 1, with one reported grade 2 event.

Currently, isatuximab is the only anti-CD38 monoclonal antibody in multiple myeloma that offers the flexibility of both SC OBI and administration through manual injection.

Reference:
Sanofi’s Sarclisa subcutaneous approved in the EU as the first anticancer treatment administered via an on-body injector. Sanofi press release. June 8, 2026.