Sarclisa Subcutaneous Gains Second Global Approval with Multiple Myeloma Authorisation in Japan

(IN BRIEF) Sanofi has received approval from Japan’s Ministry of Health, Labour and Welfare for the subcutaneous formulation of Sarclisa, or isatuximab, in combination with approved standard-of-care regimens for multiple myeloma. The approval covers use with pomalidomide and dexamethasone, or with carfilzomib, for relapsed or refractory multiple myeloma, as well as use with bortezomib, lenalidomide and dexamethasone for adult patients with newly diagnosed multiple myeloma. The decision is the second global approval for Sarclisa subcutaneous following the European Union and is supported by multiple studies, including the pivotal IRAKLIA phase 3 trial, which showed non-inferior efficacy and pharmacokinetics compared with intravenous Sarclisa. In IRAKLIA, Sarclisa subcutaneous administered through an on-body injector with pomalidomide and dexamethasone achieved a 71.1% objective response rate, compared with 70.5% for the intravenous regimen. A regulatory submission for the CirCLIQ on-body injector is also under review in Japan, and if approved, Sarclisa subcutaneous could become the first anticancer treatment in Japan to be administered through an on-body injector.

(PRESS RELEASE) PARIS, 19-Jun-2026 — /EuropaWire/ — Sanofi has received approval from Japan’s Ministry of Health, Labour and Welfare for the subcutaneous formulation of Sarclisa, also known as isatuximab, for the treatment of patients with multiple myeloma.

The approval covers Sarclisa subcutaneous in combination with approved standard-of-care regimens for multiple myeloma. In Japan, the newly approved indications include use with pomalidomide and dexamethasone, or with carfilzomib, for patients with relapsed or refractory multiple myeloma, as well as use with bortezomib, lenalidomide and dexamethasone for adult patients with newly diagnosed multiple myeloma.

The decision marks the second global approval for Sarclisa subcutaneous following approval in the European Union. It also represents another step in Sanofi’s efforts to make multiple myeloma treatment more convenient for patients by reducing the treatment burden associated with intravenous administration.

A regulatory submission for the CirCLIQ on-body injector, which is based on Enable Injections’ enFuse platform and was submitted by Enable Injections, is currently under review in Japan. If approved, Sarclisa subcutaneous could become the first anticancer treatment in Japan to be administered through an on-body injector and the first multiple myeloma medicine in the country to offer both manual subcutaneous injection and on-body injector administration.

Multiple myeloma diagnoses have been increasing steadily in Japan in recent years, creating a need for additional treatment options, particularly in the front-line setting. Multiple myeloma is the third most common hematologic malignancy in Japan.

Olivier Nataf, Global Head of Oncology at Sanofi, said the approval of Sarclisa subcutaneous represents an important development in the delivery of care for multiple myeloma patients in Japan. He said the new formulation can significantly ease treatment burden and improve convenience compared with intravenous administration, while also carrying the potential to become Japan’s first anticancer therapy delivered through an on-body injector if that device receives approval.

The Japanese approval is based on results from multiple studies, including the pivotal IRAKLIA phase 3 study in relapsed or refractory multiple myeloma. The study demonstrated that the subcutaneous formulation of Sarclisa was non-inferior to the intravenous formulation in terms of efficacy and pharmacokinetics.

IRAKLIA evaluated Sarclisa subcutaneous administered through an on-body injector in combination with pomalidomide and dexamethasone, compared with Sarclisa intravenous in combination with the same regimen. The study enrolled adult patients with relapsed or refractory multiple myeloma who had received at least one prior line of therapy.

In the trial, Sarclisa subcutaneous administered via an on-body injector with pomalidomide and dexamethasone produced an objective response rate of 71.1%, compared with 70.5% for Sarclisa intravenous with pomalidomide and dexamethasone. These results established non-inferiority for the subcutaneous formulation.

The overall safety profile of Sarclisa subcutaneous with pomalidomide and dexamethasone was consistent with the established safety profile of the intravenous formulation. Infusion reactions were reported in 25% of patients treated with Sarclisa intravenous, compared with 1.5% of patients treated with the subcutaneous formulation.

No new safety concerns were observed, apart from low-grade local injection-site reactions, which occurred in 0.4% of on-body injector injections. Nearly all injection-site reactions were grade 1, with one reported grade 2 episode.

The most common grade 3 or higher non-hematologic adverse events included pneumonia, COVID-19 and upper respiratory tract infection. The most common grade 3 or higher hematologic laboratory abnormalities included neutropenia, thrombocytopenia and anemia.

In Japan, Sarclisa intravenous is already approved across five indications. These include use in combination with bortezomib, lenalidomide and dexamethasone for newly diagnosed multiple myeloma, as well as four regimens for relapsed or refractory multiple myeloma, including combinations with pomalidomide and dexamethasone, carfilzomib and dexamethasone, dexamethasone alone, or as monotherapy.

Sarclisa subcutaneous administered through both the CirCLIQ on-body injector and manual injection was approved in the European Union in June 2026 for multiple myeloma patients across all currently approved indications and combinations for the intravenous formulation. An application for Sarclisa subcutaneous administered through both on-body injector and manual injection is also under review in the United States.

About the IRAKLIA study
IRAKLIA (clinical study identifier: NCT05405166) was a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa administered at a fixed dose SC via OBI versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM who have received at least one prior line of therapy. The co-primary outcomes assessed were ORR, defined as the proportion of patients with stringent complete response (CR), CR, very good partial response, and partial response according to the 2016 International Myeloma Working Group criteria assessed by Independent Review Committee, and observed Sarclisa mean concentration before dosing (Ctrough) at steady state (pre-dose at cycle 6, dose 1 [C6D1]), defined as observed Sarclisa plasma concentrations.

About Enable Injections
Cincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse® On-Body Delivery System. An innovative wearable technology, the enFuse system is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information, visit www.enableinjections.com.

About Sarclisa
Sarclisa (isatuximab) has been approved in almost 60 countries across four indications for certain patients with NDMM and R/R MM. Sarclisa-based regimens have been prescribed to treat more than 70,000 patients worldwide.

Sarclisa SC is approved in the EU and the UK in combination with approved standard-of-care regimens for the treatment of patients with MM across all currently approved indications for Sarclisa IV in these countries. It is the first anticancer treatment to be administered through an OBI, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both SC OBI and manual injection administration.

Sarclisa SC is approved in Japan in combination with VRd, for the treatment of adult patients with NDMM, as well as Pd and Kd for the treatment of patients with R/R MM.

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.

For more information on Sarclisa clinical studies, please visit www.clinicaltrials.gov.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Sanofi forward-looking statements
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Sarclisa Subcutaneous Gains Second Global Approval with Multiple Myeloma Authorisation in Japan

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