PARIS | June 19, 2026
Sanofi announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the subcutaneous (SC) formulation of Sarclisa (isatuximab) in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM). The approval covers use with pomalidomide and dexamethasone (Pd) and carfilzomib-based therapy for relapsed or refractory multiple myeloma (R/R MM), as well as with bortezomib, lenalidomide, and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma (NDMM). This represents the second global approval for Sarclisa SC following its recent authorization in the European Union, strengthening Sanofi’s oncology portfolio while offering patients a more convenient alternative to intravenous treatment. The company also confirmed that the CirCLIQ on-body injector (OBI) remains under regulatory review in Japan and, if approved, could become Japan’s first anticancer therapy administered through an on-body injector.
Phase III IRAKLIA Trial Demonstrated Non-Inferior Efficacy
The Japanese approval is supported primarily by results from the pivotal Phase III IRAKLIA trial, which demonstrated that Sarclisa SC achieved non-inferior efficacy and pharmacokinetics compared with the currently approved intravenous (IV) formulation. In adults with relapsed or refractory multiple myeloma who had received at least one prior therapy, Sarclisa SC combined with pomalidomide and dexamethasone achieved a 71.1% objective response rate (ORR), compared with 70.5% for Sarclisa IV, successfully meeting the study’s primary endpoint for non-inferiority. The study also showed a favorable safety profile consistent with the established IV formulation. Importantly, infusion-related reactions were significantly reduced, occurring in only 1.5% of patients receiving the SC formulation compared with 25% among patients receiving intravenous treatment. Low-grade injection-site reactions remained uncommon, occurring in only 0.4% of more than 5,100 on-body injector administrations, with no unexpected safety concerns identified.
Subcutaneous Formulation May Improve Patient Experience
The newly approved subcutaneous formulation has been developed to simplify treatment delivery while reducing the burden associated with lengthy intravenous infusions. In addition to traditional manual subcutaneous injection, Sanofi is pursuing approval of the CirCLIQ on-body injector, developed using Enable Injections’ enFuse® platform, to provide patients with an automated wearable administration option. If authorized, the technology would make Sarclisa the first anticancer therapy in Japan available through an on-body injector, offering enhanced flexibility and convenience for both patients and healthcare providers. With multiple myeloma representing the third most common hematologic malignancy in Japan and diagnoses continuing to rise, innovative treatment approaches that improve patient experience without compromising efficacy remain an important clinical priority.
Advertisement
Global Expansion Strengthens Sarclisa Franchise
The latest approval further expands the global presence of Sarclisa, which is now approved in nearly 60 countries across multiple indications for newly diagnosed and relapsed or refractory multiple myeloma, with more than 70,000 patients treated worldwide. Earlier in June 2026, the European Union approved Sarclisa SC across all currently authorized indications for the intravenous formulation, including both manual injection and on-body injector administration. Regulatory review of the same formulation is also ongoing in the United States, highlighting Sanofi’s strategy to broaden access to more convenient treatment options for patients living with multiple myeloma. The Japan approval reinforces the company’s continued commitment to advancing innovative oncology therapies that improve treatment delivery while maintaining high standards of clinical efficacy and safety.
Source: Sanofi press release
