Sanofi’s Sarclisa subcutaneous formulation wins approval in Japan for patients with multiple myeloma

Japan’s Ministry of Health, Labour and Welfare has granted approval for Sarclisa (isatuximab) in its subcutaneous formulation, to be used alongside established standard-of-care regimens in the treatment of multiple myeloma. Approved combinations in Japan cover use with pomalidomide and dexamethasone, or with carfilzomib, in relapsed or refractory multiple myeloma, as well as use with bortezomib, lenalidomide, and dexamethasone in adults with newly diagnosed multiple myeloma.

A separate regulatory submission for the CirCLIQ on-body injector, built on the enFuse platform and filed by Enable Injections, remains under active review in Japan. If that submission succeeds, Sarclisa SC could become the first anticancer treatment delivered via an on-body injector in the country, and the first multiple myeloma medicine in Japan available through both manual subcutaneous injection and on-body injector administration.

New multiple myeloma diagnoses have been climbing steadily in Japan in recent years, highlighting a growing need for additional treatment approaches, particularly at the front-line stage. Multiple myeloma ranks as the third most common blood cancer in the country.

“Today’s approval of Sarclisa subcutaneous represents an important evolution in how we deliver care for multiple myeloma patients in Japan,” said Olivier Nataf, Global Head of Oncology at Sanofi. “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.”

Evidence supporting the approval comes from the IRAKLIA Phase 3 study in relapsed or refractory multiple myeloma, which established that the subcutaneous formulation performs on a non-inferior basis to the intravenous version in terms of both efficacy and pharmacokinetics, alongside a body of further supportive research. Both manual subcutaneous injection and OBI-administered Sarclisa SC were evaluated across these studies, using Enable Injections’ enFuse hands-free on-body injector for automated subcutaneous delivery.

Within the IRAKLIA study, Sarclisa SC delivered via an on-body injector combined with pomalidomide and dexamethasone achieved an objective response rate of 71.1%, set against 70.5% for the intravenous formulation with the same regimen, confirming non-inferiority among adults with relapsed or refractory multiple myeloma who had received at least one prior treatment line. The safety profile seen with Sarclisa SC combined with pomalidomide and dexamethasone remained consistent with what is already known about the intravenous combination. Infusion reactions occurred in 25% of patients receiving the intravenous formulation, dropping sharply to just 1.5% among those on the subcutaneous version. No previously unidentified safety issues arose, with the exception of mild localised injection site reactions in 0.4% of on-body injector administrations, nearly all of which were grade 1 severity, with a single grade 2 case on record.

Within Japan, Sarclisa IV already holds approval across five indications, covering use with bortezomib, lenalidomide, and dexamethasone in newly diagnosed multiple myeloma and four separate regimens in the relapsed or refractory setting. In Europe, Sarclisa SC via both on-body injector and manual injection received approval in June 2026 spanning all currently authorised indications and combinations for the intravenous formulation. A US application for Sarclisa SC through both administration routes is currently progressing through the regulatory process.

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Related Topics and Keywords

multiple myeloma, myeloma, sanaofi, Sanofi’s Sarclisa, sarclissa