Sanofi's Sarclisa subcutaneous formulation approved in Japan for multiple myeloma

Paris, June 19, 2026 – Japan's Ministry of Health, Labour and Welfare has approved Sanofi's Sarclisa (isatuximab) in a subcutaneous (SC) formulation for the treatment of multiple myeloma.

The approval allows Sarclisa SC to be used in combination with standard-of-care regimens for patients with relapsed or refractory multiple myeloma (R/R MM) when combined with pomalidomide and dexamethasone (Pd) or carfilzomib. It is also approved for adult patients with newly diagnosed multiple myeloma (NDMM) in combination with bortezomib, lenalidomide, and dexamethasone (VRd).

This approval is supported by data from studies including the pivotal phase 3 IRAKLIA trial, which demonstrated non-inferior efficacy and pharmacokinetics of the SC formulation compared to the intravenous (IV) form. The studies also evaluated administration via an automated on-body injector (OBI), which could make Sarclisa the first anticancer treatment in Japan administered this way.

Multiple myeloma is the third most common hematologic malignancy in Japan, with a rising incidence. The subcutaneous formulation of Sarclisa offers patients a more convenient and less burdensome treatment option compared to intravenous infusion. Reported adverse events were primarily mild, localized injection site reactions.