Japan has approved Sanofi’s subcutaneous Sarclisa (isatuximab) for newly diagnosed and relapsed/refractory multiple myeloma, supported by Phase 3 IRAKLIA data showing efficacy comparable to intravenous administration with fewer administration-related reactions.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Sanofi has received approval from Japan’s Ministry of Health, Labour and Welfare for the subcutaneous (SC) formulation of Sarclisa (isatuximab) in combination with approved standard-of-care regimens for patients with multiple myeloma (MM).
The approval expands treatment options for both newly diagnosed multiple myeloma (NDMM) and relapsed or refractory multiple myeloma (R/R MM), offering a more convenient alternative to intravenous (IV) administration.
The approval covers Sarclisa SC in combination with pomalidomide and dexamethasone (Pd) or carfilzomib-based regimens for R/R MM, as well as in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with NDMM.
The decision marks the second global approval for Sarclisa SC following its recent authorization in Europe.
Scientific and Clinical Context
Sarclisa is a monoclonal antibody that targets CD38, a protein highly expressed on multiple myeloma cells. By binding to CD38, the therapy promotes immune-mediated destruction of malignant plasma cells and has become an established treatment option across several multiple myeloma settings.
Multiple myeloma remains the third most common hematologic cancer in Japan. The growing number of newly diagnosed patients has increased demand for therapies that can maintain efficacy while reducing treatment burden and healthcare resource utilization.
The subcutaneous formulation offers shorter administration times compared with intravenous infusion and may improve treatment convenience for patients and care teams.
Phase 3 IRAKLIA Study Supported Approval
Japan’s approval was primarily supported by findings from the pivotal Phase 3 IRAKLIA trial (NCT05405166), which evaluated fixed-dose subcutaneous Sarclisa administered through an on-body injector (OBI) versus weight-based intravenous Sarclisa, both combined with pomalidomide and dexamethasone in adults with R/R MM who had received at least one prior therapy.
The study met its primary objective, demonstrating non-inferior efficacy for the SC formulation. The objective response rate (ORR) reached 71.1% in the Sarclisa SC arm compared with 70.5% in the IV arm (risk ratio 1.008; 95% CI: 0.903-1.126; p=0.0006).
Safety
Safety findings were consistent with the established profile of intravenous Sarclisa. Notably, infusion-related reactions occurred in 25% of patients receiving IV treatment compared with only 1.5% of patients treated with the SC formulation. Injection-site reactions were uncommon, occurring in just 0.4% of OBI administrations, and were predominantly low-grade.
The most frequent grade 3 or higher non-hematologic adverse events included pneumonia, COVID-19, and upper respiratory tract infections. Common hematologic laboratory abnormalities included neutropenia, thrombocytopenia, and anemia.
Toward On-Body Injector Administration in Oncology
Alongside the SC approval, Japanese regulators are reviewing Sanofi’s submission for the CirCLIQ on-body injector, developed using Enable Injections’ enFuse platform. If authorized, Sarclisa could become the first anticancer therapy administered through an on-body injector in Japan and the first multiple myeloma treatment available through both manual SC injection and wearable OBI delivery.
Commenting on the approval, Olivier Nataf, Global Head of Oncology at Sanofi, said the new formulation represents an important advance in treatment delivery by reducing administration burden while improving convenience for patients.
Clinical Path Forward
Sarclisa IV is already approved across five indications in Japan, including frontline and relapsed/refractory multiple myeloma settings. The new SC formulation broadens administration options while preserving clinical efficacy.
Beyond Japan, Sarclisa SC recently gained approval in Europe across all currently authorized indications for the IV formulation. A regulatory application covering both manual SC injection and OBI administration remains under review in the United States, potentially setting the stage for further global expansion of the therapy.
What This Means for Patients in Japan
For people in Japan living with multiple myeloma, this approval offers a more convenient way to receive Sarclisa, an established treatment used for both newly diagnosed and relapsed disease. In clinical studies, the subcutaneous formulation worked as well as the intravenous version while causing fewer treatment-related administration reactions. This may help reduce the stress and inconvenience often associated with repeated hospital visits and lengthy infusions. As multiple myeloma cases continue to increase in Japan, the availability of a faster and less burdensome treatment option could improve the overall treatment experience for many patients. If the wearable on-body injector is approved in the future, some patients may have an additional administration option that could make receiving treatment even more convenient.
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About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.