Sanofi: Green Light in Japan for Subcutaneous Sarclisa Injection
On Friday, Sanofi received regulatory approval from the Japanese Ministry of Health for the subcutaneous injection formulation of its Sarclisa (isatuximab), intended for the treatment of multiple myeloma. This approval is based on the results of the phase 3 IRAKLIA study, which demonstrated the non-inferiority of the treatment compared to its intravenous formulation.
Approval Based on Non-Inferiority Results
The Japanese approval covers several indications of Sarclisa in subcutaneous injection. The treatment is approved in combination with pomalidomide and dexamethasone, or carfilzomib, for patients with relapsed or refractory multiple myeloma (R/R MM). It is also approved in combination with bortezomib, lenalidomide, and dexamethasone for adult patients with newly diagnosed multiple myeloma (NDMM).
The approval is based on data from the IRAKLIA study, a randomized phase 3 trial that evaluated the non-inferiority of the subcutaneous formulation compared to the intravenous form in combination with pomalidomide and dexamethasone. In this trial, the objective response rate reached 71.1% in patients treated with Sarclisa SC administered by a portable auto-injector, compared to 70.5% for the IV formulation, establishing non-inferiority.
Enhanced Safety and Administration via Auto-Injector
The safety profile observed in IRAKLIA for the subcutaneous formulation is consistent with that of the intravenous formulation. One notable aspect is the reduction in infusion-related reactions. While 25% of patients treated with IV experienced infusion reactions, only 1.5% of those receiving Sarclisa SC recorded any.
The subcutaneous formulation introduces a new mode of administration via a portable auto-injector (OBI) called CirCLIQ, based on the enFuse platform from Enable Injections. This auto-injector generated reactions at the injection site (0.4% of the 5,145 injections), almost all of grade 1, with the exception of one episode of grade 2. An approval application dossier for CirCLIQ is currently under review in Japan. If approved, Sarclisa could become the first cancer treatment administered by a portable auto-injector in the country, and the first Japanese multiple myeloma treatment offering both manual and automated injection modalities.
Global Expansion and Therapeutic Context
This Japanese approval represents the second global approval for Sarclisa in subcutaneous formulation, following the one obtained in the European Union in June 2026. An approval application is currently under review in the United States.
In Japan, multiple myeloma is among the three most common malignant hematologic diseases. Sanofi indicates that new diagnoses of multiple myeloma have been steadily increasing in recent years, creating a need for new therapeutic approaches, particularly in the front line of treatment. Sarclisa IV already has five approved indications in Japan, covering newly diagnosed and relapsed or refractory forms according to various therapeutic combinations.
