Sanofi Gains EU Approval for Sarclisa SC via On-Body Injector, First Anticancer OBI Approval

A new drug-device combination classification has entered EU oncology manufacturing: Sanofi's Sarclisa (isatuximab) subcutaneous formulation received European Commission approval on 8 June 2026, becoming the first anticancer therapy in the EU administered via an on-body injector (OBI), the CirCLIQ device. For plant heads and QA directors, the approval signals that OBI fill-finish and device-drug combination validation are no longer peripheral considerations in oncology manufacturing strategy.

The SC formulation covers all four existing EU indications previously held by the intravenous formulation, including combinations with bortezomib, lenalidomide, and dexamethasone in both transplant-eligible and transplant-ineligible newly diagnosed multiple myeloma, and combinations with pomalidomide or carfilzomib in relapsed/refractory disease. The CHMP positive opinion was grounded in the pivotal IRAKLIA phase 3 study (NCT05405166), which demonstrated non-inferiority of the SC formulation versus IV across these indications.

From a regulatory pathway standpoint, the approval establishes a precedent under EMA's combination product framework for oncology biologics delivered via wearable injection systems. QA leads managing device-drug combination submissions will need to account for OBI-specific process validation requirements, including fill-finish compatibility, device component qualification, and sterility assurance across the combined system. ICH Q10 pharmaceutical quality system principles apply across both the drug product and device interface, and any CAPA architecture will need to span both domains.

Patient satisfaction data from IRAKLIA reinforces the commercial rationale: 70% of patients receiving Sarclisa SC via OBI reported satisfaction or high satisfaction with their injection, compared to 53.4% for IV administration (OR 2.036; 95% CI: 1.425–2.908; p=0.0001). The IZALCO phase 2 study further indicated that both patients and healthcare providers preferred OBI over manual SC administration. Sanofi reports Sarclisa has been prescribed to nearly 70,000 patients worldwide since its 2020 launch, providing a substantial post-market surveillance base for the IV formulation against which SC safety data will be benchmarked.

The approval also introduces home and outpatient administration as viable delivery settings for an anti-CD38 monoclonal antibody, a shift that carries supply-chain and cold-chain implications for manufacturers and distributors managing last-mile integrity for a biologic in a wearable device format.

The IRAKLIA non-inferiority data and the CHMP opinion together form the regulatory anchor that future OBI-based oncology submissions in the EU will likely reference as a comparator pathway.

Source: Sanofi via GlobeNewswire, 8 June 2026.