Sanofi’s Sarclisa Gains European Approval for Flexible Subcutaneous Multiple Myeloma Treatment Using CirCLIQ On-Body Injector

Sanofi’s Sarclisa Gains European Approval for Flexible Subcutaneous Multiple Myeloma Treatment Using CirCLIQ On-Body Injector

(IN BRIEF) Sanofi has secured European Commission approval for Sarclisa® subcutaneous administration in combination with standard-of-care regimens for multiple myeloma, covering all indications already approved for the intravenous version of the therapy in the EU. The approval makes Sarclisa the first anticancer treatment in Europe to be administered through an on-body injector and the first multiple myeloma therapy available through both OBI-based subcutaneous delivery and manual subcutaneous injection. Used with Enable Injections’ CirCLIQ® OBI, the new administration option is designed to make treatment delivery more flexible, including use in outpatient settings and, where permitted, at home. The approval is supported by the pivotal IRAKLIA phase 3 study, which demonstrated non-inferiority of Sarclisa SC delivered via OBI compared with IV administration, along with data showing strong patient satisfaction and preference for the OBI approach. Sanofi said the development builds on Sarclisa’s established safety and efficacy profile, with the therapy already prescribed to nearly 70,000 patients worldwide and approved in almost 60 countries across multiple indications for newly diagnosed and relapsed and/or refractory multiple myeloma.

(PRESS RELEASE) PARIS, 8-Jun-2026 — /EuropaWire/ — Sanofi has received approval from the European Commission for Sarclisa® (isatuximab) subcutaneous (SC) administration in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all indications currently approved for the intravenous (IV) formulation of Sarclisa in the European Union.

The approval marks an important milestone in cancer care, making Sarclisa the first anticancer therapy in the EU that can be administered through an on-body injector (OBI). It also establishes Sarclisa as the first multiple myeloma treatment in Europe available through both an OBI-based subcutaneous delivery option and manual subcutaneous injection. The new administration route is designed to offer greater flexibility for patients and healthcare professionals, supporting treatment delivery in outpatient settings as well as, where permitted, in patients’ homes.

The subcutaneous formulation is used with Enable Injections’ CirCLIQ® OBI, an automated on-body injector developed using the enFuse® platform. The device enables Sarclisa to be delivered subcutaneously at the push of a button and is designed to simplify the treatment experience for patients receiving therapy for multiple myeloma. The injector uses a hidden retractable needle that is shorter and thinner than needles commonly used for large-volume subcutaneous injections.

Multiple myeloma is a complex blood cancer that frequently requires ongoing treatment and repeated visits to healthcare facilities. The availability of Sarclisa through an OBI introduces a more flexible approach to therapy administration, potentially helping to reduce the burden on patients, caregivers and healthcare systems.

“Multiple myeloma is a complex disease that often requires repeated and prolonged clinic visits, placing a considerable burden on patients and those who support them. There has been a need for innovative approaches to ease this aspect of the treatment journey,” said Mohamad Mohty, MD, PhD, Professor of Hematology at Sorbonne University and Head of the Clinical Hematology and Cellular Therapy Department at Saint-Antoine Hospital in Paris, France. “The ability to administer a therapy through an on-body injector, particularly an anti-CD38 monoclonal antibody with well-established efficacy, either in the clinic or at home represents a meaningful step forward. With this new option now approved, we have an opportunity to reduce pressure on healthcare systems while placing greater flexibility and convenience at the heart of patient-centered care.”

Sarclisa IV has been available since 2020 and is approved in the EU across four indications. These include use in combination with bortezomib, lenalidomide and dexamethasone for both transplant-ineligible newly diagnosed multiple myeloma and transplant-eligible newly diagnosed multiple myeloma. In relapsed and/or refractory multiple myeloma, Sarclisa is approved in combination with pomalidomide and dexamethasone, or with carfilzomib and dexamethasone.

The European Commission’s decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is supported by data from the pivotal IRAKLIA phase 3 study in relapsed and/or refractory multiple myeloma, along with additional clinical studies. The IRAKLIA study demonstrated the non-inferiority of Sarclisa SC administered via an OBI compared with the IV formulation.

“Our approach to innovation in cancer care is grounded in real-world impact, both advancing treatment and improving how care is delivered,” said Olivier Nataf, Global Head of Oncology at Sanofi. “Sarclisa, which has been prescribed to nearly 70,000 patients worldwide, already brings a well-established safety and efficacy profile across the multiple myeloma care continuum. With today’s EU approval, we’re combining that foundation with the added convenience, flexibility, and accessibility of the CirCLIQ on-body injector, which could offer a meaningful difference in the treatment experience.”

Clinical findings from the IRAKLIA and IZALCO studies suggest that use of an on-body injector may provide greater simplicity, flexibility, convenience and patient satisfaction compared with IV administration. The studies also indicate that both patients and healthcare providers preferred OBI administration over manual subcutaneous injection.

In the IRAKLIA phase 3 study, 70% of patients receiving Sarclisa SC through an OBI reported being satisfied or very satisfied with their injection, compared with 53.4% of patients receiving Sarclisa IV. In the IZALCO phase 2 study, after experiencing both OBI and manual subcutaneous administration, 74.5% of patients preferred Sarclisa SC delivered via an OBI, while 17% preferred manual injection and 8.5% expressed no preference.

IRAKLIA was the first phase 3 study to include the use of an on-body injector in the treatment of multiple myeloma. In the study, Sarclisa SC administered via an OBI in combination with pomalidomide and dexamethasone achieved an objective response rate of 71.1%, compared with 70.5% for Sarclisa IV in combination with pomalidomide and dexamethasone. These results established non-inferiority in adult patients with relapsed and/or refractory multiple myeloma who had received at least one prior line of treatment.

The overall safety profile of Sarclisa SC in combination with pomalidomide and dexamethasone was consistent with the established safety profile of the IV regimen. Systemic infusion reactions were reported in 25% of patients treated with Sarclisa IV, compared with 1.5% of patients treated with Sarclisa SC. No new safety concerns were identified, apart from low-grade local injection site reactions, which occurred in 0.4% of OBI injections. Nearly all injection site reactions were grade 1, with one grade 2 event reported.

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

In countries where at-home administration was permitted, the median injection duration for Sarclisa SC via OBI was 13 minutes in both clinic and home settings. Home administration was well tolerated, all injections were completed and no new safety signals were observed.

About the IRAKLIA study 
IRAKLIA (clinical study identifier: NCT05405166) was a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa SC 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 (IRC), and observed Sarclisa SC mean concentration before dosing (Ctrough) at steady state (pre-dose at cycle 6, dose 1 [C6D1]), defined as observed Sarclisa SC plasma concentrations.

About the IZALCO study
IZALCO (clinical study identifier: NCT05704049) was a two-part randomized, open-label phase 2 study evaluating the efficacy and safety of Sarclisa SC administered via an OBI or by manual push, in combination with Kd, for the treatment of patients with R/R MM who have received one to three prior lines of therapy. The primary objective was ORR, as assessed by IRC. The secondary objectives were patient and healthcare provider preference for the OBI versus manual administration of Sarclisa SC.

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 nearly 70,000 patients worldwide.

Sarclisa subcutaneous is approved in the EU in combination with approved standard-of-care regimens for the treatment of patients with MM across all currently approved indications for Sarclisa IV in the EU. 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. Additional regulatory submissions for Sarclisa subcutaneous are currently under review with regulatory authorities worldwide, including in the United States, China, and Japan.

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

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SOURCE: Sanofi