EU Approves Sarclisa On-Body Injector Option for Multiple Myeloma

The European Commission has approved subcutaneous (SC) Sarclisa® (isatuximab) across all existing EU indications for multiple myeloma, making it the first anticancer therapy in Europe available through an on-body injector (OBI). The approval covers both newly diagnosed and relapsed or refractory multiple myeloma and extends to all EU member states and EEA countries.

Sarclisa is a CD38-directed monoclonal antibody that targets malignant plasma cells. The new formulation provides an alternative to intravenous (IV) administration while maintaining the same approved indications.

Administration Flexibility

Sarclisa SC can be administered using Enable Injections’ CirCLIQ® OBI or by manual subcutaneous injection, offering greater flexibility for patients and healthcare providers. The wearable injector supports administration in outpatient settings and, where permitted, at home, helping reduce the burden of repeated clinic visits.

The CirCLIQ OBI uses a hidden retractable needle and delivers treatment through an automated push-button system, introducing a new administration option for anti-CD38 therapy in Europe.

Clinical Evidence

The approval was primarily supported by the pivotal Phase 3 IRAKLIA trial (NCT05405166), which compared fixed-dose SC Sarclisa plus pomalidomide and dexamethasone (Pd) delivered via OBI with weight-based IV Sarclisa-Pd in adults with relapsed or refractory multiple myeloma who had received at least one prior therapy.

The study met its primary endpoint, demonstrating non-inferiority of the SC formulation. Objective response rates were 71.1% with SC Sarclisa-Pd and 70.5% with IV Sarclisa-Pd (risk ratio 1.008; 95% CI: 0.903–1.126; p=0.0006).

Safety findings were consistent with the established IV profile. Systemic infusion-related reactions occurred in 1.5% of patients receiving SC Sarclisa compared with 25% of those receiving IV therapy. Injection-site reactions were uncommon, occurring in only 0.4% of more than 5,100 OBI administrations and were almost entirely low grade.

The most common grade 3 or higher nonhematologic adverse events included pneumonia, COVID-19, and upper respiratory tract infections. The most frequent hematologic toxicities were neutropenia, thrombocytopenia, and anemia. No new safety concerns were identified.

Among patients eligible for home administration, median injection time was 13 minutes in both clinic and home settings, with all home injections completed successfully and no new safety signals reported.

Patient Preference and Satisfaction

Additional evidence came from the Phase 2 IZALCO study (NCT05704049), which compared OBI delivery with manual SC administration. After experiencing both methods, 74.5% of patients preferred OBI administration, while 17% preferred manual injection.

In IRAKLIA, 70% of patients receiving OBI-administered Sarclisa reported being satisfied or very satisfied with treatment versus 53.4% of patients receiving IV therapy, highlighting the appeal of a simplified administration experience.

Path Toward Broader Adoption

Since its 2020 launch, Sarclisa-based regimens have been prescribed to nearly 70,000 patients worldwide and are approved in almost 60 countries.

Regulatory reviews of the SC formulation remain ongoing in the United States, China, Japan, and other markets. The EU approval expands treatment flexibility for patients with multiple myeloma and introduces the first oncology on-body injector platform into routine cancer care.

Reference

Press Release: Sanofi’s Sarclisa subcutaneous approved in the EU as the first anticancer treatment administered via an on-body injector