Sanofi's Sarclisa Subcutaneous Formulation Approved in Japan for Multiple Myeloma
Japan's Ministry of Health, Labour and Welfare has approved Sanofi's Sarclisa (isatuximab) subcutaneous formulation for the treatment of multiple myeloma. The approval offers new administration options for patients.
Paris, June 19, 2026 – The Ministry of Health, Labour and Welfare in Japan has approved Sanofi's Sarclisa (isatuximab) subcutaneous (SC) formulation for the treatment of multiple myeloma (MM). This approval expands treatment options for patients in Japan.
The approved indications for Sarclisa SC in Japan include its use in combination with pomalidomide and dexamethasone (Pd) for relapsed or refractory MM (R/R MM). It is also approved in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adult patients with newly diagnosed multiple myeloma (NDMM).
Sanofi is also awaiting review for its CirCLIQ on-body injector (OBI) in Japan. If approved, Sarclisa SC could become the first anticancer treatment administered via an OBI in Japan, and the first MM medicine offering both manual SC injection and OBI administration. This aims to reduce treatment burden and enhance convenience.
The approval is based on data from the pivotal IRAKLIA phase 3 study, which demonstrated non-inferior efficacy and pharmacokinetics of the SC formulation compared to the intravenous (IV) form. The study showed an objective response rate (ORR) of 71.1% for SC-administered Sarclisa in combination with Pd, compared to 70.5% for IV-administered Sarclisa-Pd. The safety profile of the SC formulation was consistent with the IV form, with fewer infusion reactions and only mild local injection site reactions.