Sanofi (SNY) announced that the Ministry of Health, Labour, and Welfare, or MHLW, in Japan, has granted clearance for the Sarclisa subcutaneous (SC) formulation in combination with approved standard-of-care (SOC) regimens for the treatment of Multiple Myeloma (MM).
Sarclisa, also known as isatuximab, is an anti-CD38 monoclonal antibody used in the treatment of MM that provides the option for both SC administration via the on-body injector (OBI) and manual injection.
In Japan, Sarclisa SC has been approved in combination with pomalidomide and dexamethasone (Pd), or with carfilzomib and dexamethasone (Kd), for relapsed or refractory multiple myeloma (R/R MM) and in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adult patients with newly diagnosed MM (NDMM).
Sarclisa, in conjunction with the CirCLIQ on-body injector (OBI), an automated injector, helps deliver Sarclisa subcutaneously in outpatient and home settings.
In addition, the regulatory submission for the CirCLIQ OBI by Enable Injections is currently under review in Japan. If approved, Sarclisa SC could become the first anticancer therapy administered via an OBI and the first MM treatment in Japan to offer both manual SC injection and OBI administration, according to the company.
The company noted the approval was based on encouraging results from the pivotal IRAKLIA phase 3 study in R/R MM, which demonstrated non-inferiority of Sarclisa SC administered as a fixed subcutaneous dose via OBI compared with weight-based intravenous (IV) Sarclisa, both in combination with Pd, in adult patients who had received at least one prior line of therapy.
According to the phase 3 IRAKLIA study, Sarclisa SC, administered using OBI in combination with Pd, resulted in a 71.1% objective response rate (ORR), compared with 70.5% with Sarclisa IV-Pd. This established non-inferiority in patients with R/R MM who had previously received one line of treatment.
The company noted the overall safety profile of Sarclisa SC-Pd was consistent with the established safety profile of Sarclisa IV-Pd. In 25% of patients treated with Sarclisa IV-Pd and in 1.5% of patients treated with Sarclisa SC-Pd, infusion reactions occurred.
Notably, In June 2026, the European Commission approved Sarclisa (isatuximab) for subcutaneous (SC) administration via both the CirCLIQ OBI and manual injection, in combination with standard-of-care regimens for multiple myeloma, across all existing indications for the intravenous (IV) formulation.
Additionally, an application for Sarclisa SC administered via both OBI and manual injection is currently under review in the U.S.
SNY closed Thursday's trade at $42.38, down 0.28%. In the pre-market, the shares are trading at $41.47, down 2.15%.
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Business News
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