Sanofi Gains Japan Approval for Sarclisa Subcutaneous Formulation in Multiple Myeloma

Japan's approval of a subcutaneous formulation of isatuximab (Sarclisa) puts Sanofi's fill-finish and device integration strategy under direct operational scrutiny, as the country's Ministry of Health, Labour and Welfare granted the nod on 19 June 2026 for use across both relapsed/refractory and newly diagnosed multiple myeloma indications.

The approval covers Sarclisa SC in combination with pomalidomide and dexamethasone (Pd) or carfilzomib for relapsed/refractory MM, and with bortézomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed patients. It marks the second global approval for the SC formulation following the EU, and is supported by the Phase 3 IRAKLIA study (NCT05405166), which demonstrated non-inferiority against the intravenous reference: objective response rates of 71.1% (SC via on-body injector) versus 70.5% (IV), with a risk ratio of 1.008 (95% CI: 0.903–1.126; p = 0.0006).

For QA and regulatory leads, the safety profile warrants close reading. Infusion reactions dropped from 25% with IV-Pd to 1.5% with SC-Pd. Injection-site reactions (ISRs) occurred in 0.4% of on-body injector administrations (19 of 5,145 injections), with nearly all graded as Grade 1 and one Grade 2 event recorded. Grade ≥3 non-haematological adverse events, including pneumonia at 14.8% (OBI) versus 15.5% (IV), remained broadly comparable across arms.

A separate marketing authorisation application for the CirCLIQ on-body injector, built on Enable Injections' enFuse platform, remains under review by Japanese regulators. If approved, Sarclisa SC would become the first oncology treatment in Japan administered via an on-body injector and the first multiple myeloma therapy available through both manual SC injection and OBI delivery. The device integration pathway here is consequential: manufacturers transitioning oncology biologics from IV to SC formats must align formulation stability data, primary container qualification, and device-drug combination dossiers within a single regulatory submission strategy.

Multiple myeloma is the third most common haematological malignancy in Japan, with new diagnoses rising steadily in recent years, sustaining demand for first-line and later-line treatment options.

The pending CirCLIQ review represents a measurable regulatory checkpoint that will determine whether Sanofi's on-body injector strategy achieves full commercial deployment in Japan.

Source: Sanofi via GlobeNewswire, 19 June 2026.