French drug major Sanofi (SNY,SAN.PA) announced Friday that Sarclisa (isatuximab) subcutaneous (SC) formulation combination therapy has been approved in Japan for patients with multiple myeloma.
In a statement, the company that the Ministry of Health, Labour and Welfare in Japan has granted approval for Sarclisa SC formulation in combination with approved standard-of-care regimens for the treatment of multiple myeloma.
According to the firm, 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 or NDMM.
The approval is based on results from the IRAKLIA phase 3 study in R/R MM, which demonstrated non-inferiority of the SC formulation compared to IV, as well as supportive studies.
The company added that 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 through an OBI. It would also be the first MM medicine in Japan to offer both manual SC injection and OBI administration.
Olivier Nataf, Global Head of Oncology at Sanofi, stated, "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."
In Japan, Sarclisa IV is currently approved across five indications, including in combination with VRd in NDMM, as well as four different treatment regimens in R/R MM.
Sanofi noted that Sarclisa SC administered through both the CirCLIQ OBI and manual injection was approved in the EU for the treatment of MM patients across all currently approved indications and combinations for Sarclisa IV formulation in June 2026.
Further, an application for Sarclisa SC administered through both OBI and manual injection is currently under review in the US.
In Paris, Sanofi shares were trading at 74.75 euros, up 1.92 percent.
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