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Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myeloma
Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple
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Sanofi’s Sarclisa subcutaneous formulation approved in Japan for patients with multiple myelomaApproval based on multiple studies, including the pivotal IRAKLIA phase 3 study which demonstrated non-inferior efficacy and pharmacokinetics compared to Sarclisa IVSecond global approval for Sarclisa SC following the EUParis, June 19, 2026. The Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa (isatuximab) subcutaneous (SC) formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approved indications for Sarclisa SC in Japan include in combination with pomalidomide and dexamethasone (Pd), or with carfilzomib for the treatment of relapsed or refractory MM (R/R MM) and in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM). A regulatory submission for the CirCLIQ on-body injector (OBI), based on the enFuse platform and submitted by Enable Injections, is under review in Japan. If approved, Sarclisa SC could become the first anticancer treatment to be administered via an OBI, and the first MM medicine in Japan to offer both manual SC injection and OBI administration. In recent years, new MM diagnoses have increased steadily in Japan, creating a need for new treatment approaches particularly in the front-line setting. MM is the third most common hematologic malignancy in Japan.“Today’s approval of Sarclisa subcutaneous represents an important evolution in how we deliver care for multiple myeloma patients in Japan,” said Olivier Nataf, Global Head of Oncology at Sanofi. “This new formulation significantly eases treatment burden and enhances convenience for patients compared to intravenous administration – with the potential to become Japan's first anticancer therapy to be administered via an on-body injector.” The approval is based on results from the IRAKLIA phase 3 study in R/R MM (clinical study identifier: NCT05405166), which demonstrated non-inferiority of the SC formulation compared to IV, as well as supportive studies. In addition to manual SC injection, these studies evaluated Sarclisa SC administered through an OBI, and were conducted using Enable Injections’ enFuse hands-free OBI, an automated injector for subcutaneous delivery of Sarclisa. In the I...