Subcutaneous Isatuximab Administered Via OBI Approved in EU for Multiple Myeloma

Subcutaneous isatuximab (Sarclisa) administered via the CirCLIQ on-body injector (OBI) has been approved in the European Union (EU) in combination with standard-of-care (SOC) regimens for the treatment of patients with multiple myeloma across all existing indications for intravenous (IV) isatuximab.¹

IV isatuximab is currently approved in the EU across 4 indications:

• In combination with bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone for patients with transplant-ineligible newly diagnosed multiple myeloma
• In combination with bortezomib, lenalidomide, and dexamethasone for patients with transplant-eligible newly diagnosed multiple myeloma
• In combination with pomalidomide (Pomalyst) and dexamethasone (Pd) for patients with relapsed and/or refractory multiple myeloma
• In combination with carfilzomib (Kyprolis) and dexamethasone for patients with relapsed and/or refractory multiple myeloma

The OBI allows for flexible treatment administration either at home or in outpatient care settings. Isatuximab is the first anticancer therapy to be administered via an approved OBI.

This regulatory decision was partially backed by data from the phase 3 IRAKLIA trial (NCT05405166), in which the efficacy of subcutaneous isatuximab administered via an OBI was noninferior compared with the efficacy of IV isatuximab in adult patients with relapsed/refractory multiple myeloma who had received at least 1 prior line of therapy. In this trial, patients who received isatuximab via an OBI in combination with Pd (n = 263) achieved an overall response rate of 71.1% vs 70.5% among those who received IV isatuximab plus Pd (n = 268; risk ratio, 1.008; 95% CI, 0.903-1.126; P = .0006).^1,2 Data from additional studies, including the phase 2 IZALCO study (NCT05704049) investigating subcutaneous isatuximab administered via OBI and manual injection in patients with relapsed/refractory multiple myeloma, also supported the approval.¹

This approval follows the granting of a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in March 2026.

“Multiple myeloma is a complex disease that often requires repeated and prolonged clinic visits, placing a considerable burden on patients and those who support them,” Mohamad Mohty, MD, PhD, a professor of hematology at the Sorbonne University and head of the Clinical Hematology and Cellular Therapy Department at the Saint-Antoine Hospital in Paris, France, stated in a news release. “There has been a need for innovative approaches to ease this aspect of the treatment journey. The ability to administer a therapy through an OBI, 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 health care systems [and place] greater flexibility and convenience at the heart of patient-centered care.”

What were the key patient satisfaction findings from the IRAKLIA and IZALCO studies?

In IRAKLIA, 70% of patients who underwent treatment with the isatuximab OBI reported being satisfied or very satisfied with their injection; this rate was 53.4% among those who received IV isatuximab (OR, 2.036; 95% CI, 1.425-2.908; P = .0001).

In IZALCO, among patients who experienced both methods of isatuximab administration, 74.5% preferred isatuximab administered via OBI over manual injection. Seventeen percent of these patients preferred manual injection, and 8.5% of patients had no preference (P = .0004).

“Our approach to innovation in cancer care is grounded in real-world impact, both advancing treatment and improving how care is delivered,” Olivier Nataf, global head of Oncology at Sanofi, added in the news release. “[Isatuximab], which has been prescribed to [approximately] 70,000 patients worldwide, already brings a well-established safety and efficacy profile across the multiple myeloma care continuum. With today’s EU approval, we’re combining that foundation with the added convenience, flexibility, and accessibility of the CirCLIQ OBI, which could offer a meaningful difference in the treatment experience.”

What is the regulatory status of subcutaneous isatuximab in the US?

On April 22, 2026, the FDA announced that it has extended the review period for the biologics license application seeking the approval of subcutaneous isatuximab-irfc (Sarclisa) administered via OBI in combination with approved SOC regimens for the treatment of patients with multiple myeloma.³ The updated target action date is July 23, 2026.

References

1. Press release: Sanofi’s Sarclisa subcutaneous approved in the EU as the first anticancer treatment administered via an on-body injector. News release. Sanofi. June 8, 2026. Accessed June 8, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-08-05-00-00-3307781
2. Ailawadhi S, Spicka I, Lu J, et al. Isatuximab (isa) subcutaneous (SC) via an on-body delivery system (OBDS) vs isa intravenous (IV), plus pomalidomide and dexamethasone (Pd) in relapsed/refractory multiple myeloma (RRMM): results of the randomized, non-inferiority, phase 3 IRAKLIA study. J Clin Oncol. 2025;43(suppl 16):7506. doi:10.1200/JCO.2025.43.16_suppl.7506
3. Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US. News release. Sanofi. April 22, 2026. Accessed June 8, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-22-05-00-00-3278646