Sanofi Wins EU Approval for Subcutaneous Sarclisa in Multiple Myeloma

Sanofi has received European Commission approval for a subcutaneous version of Sarclisa, marking a major step forward in the treatment of multiple myeloma. The approval allows Sarclisa, also known as isatuximab, to be used under the skin in combination with standard-of-care regimens across the same European Union indications already approved for the intravenous version. The new formulation can be administered through an on-body injector, giving patients and healthcare providers a more flexible option compared with traditional infusion-based treatment.

What the EU Approval Means

The European Commission’s decision is important because Sarclisa becomes the first anticancer therapy in the EU approved for administration through an on-body injector. This device is designed to deliver the medicine subcutaneously, meaning under the skin, instead of requiring a long intravenous infusion. Sanofi said the approval applies to patients with multiple myeloma across all current EU-approved uses of Sarclisa intravenous therapy.

For patients, this may reduce the time and pressure linked to repeated clinic visits. Multiple myeloma is a long-term blood cancer that often requires ongoing treatment. Many patients need frequent appointments, repeated monitoring, and combination therapy. A simpler delivery method may help make treatment more manageable, especially for people who live far from hospitals or who struggle with long infusion sessions.

How Sarclisa Works in Multiple Myeloma

Sarclisa is an anti-CD38 monoclonal antibody used in the treatment of multiple myeloma. It targets CD38, a protein found on myeloma cells, helping the immune system identify and attack cancer cells. In the EU, Sarclisa has already been approved in several combinations for both newly diagnosed and relapsed or refractory multiple myeloma. These combinations include regimens with medicines such as pomalidomide, dexamethasone, carfilzomib, bortezomib, and lenalidomide.

The newly approved subcutaneous version does not replace the science behind Sarclisa. Instead, it changes how the medicine can be delivered. This is why the approval is seen as both a medical and practical development. Patients may receive the same cancer-targeting treatment in a form that is designed to be quicker and easier to administer.

Clinical Data Behind the Decision

The approval was supported by data from the pivotal phase 3 IRAKLIA study, which compared subcutaneous Sarclisa delivered through an on-body injector with the intravenous version in adults with relapsed or refractory multiple myeloma. According to Sanofi, the study showed that the subcutaneous formulation was non-inferior to the intravenous formulation. The objective response rate was 71.1% for Sarclisa subcutaneous with pomalidomide and dexamethasone, compared with 70.5% for the intravenous version in the same type of combination.

Safety data were also encouraging. Sanofi reported that the overall safety profile of the subcutaneous version was consistent with the known safety profile of intravenous Sarclisa. Systemic infusion reactions were reported less often with the subcutaneous version than with intravenous treatment in the IRAKLIA study. Local injection-site reactions were generally low grade, and no new major safety concerns were observed.

Why the On-Body Injector Matters

The on-body injector, called CirCLIQ, was developed with Enable Injections’ technology. It is designed to deliver Sarclisa with the push of a button and may be used in outpatient or home settings where permitted. Sanofi said the injector uses a hidden retractable needle and is intended to support a more convenient treatment experience.

This could be especially meaningful for patients who need repeated treatment over a long period. Instead of spending extended time in a clinic for an infusion, some patients may be able to receive treatment in a shorter and more flexible way. In countries where home administration is allowed, Sanofi reported that median injection duration was 13 minutes and that home administration was well tolerated in the study setting.

Patient Preference and Treatment Convenience

Patient comfort is a key part of this approval story. In the IRAKLIA study, 70% of patients using Sarclisa subcutaneous through the on-body injector said they were satisfied or very satisfied with their injection, compared with 53.4% of patients receiving intravenous treatment. In the IZALCO phase 2 study, 74.5% of patients preferred the on-body injector after experiencing both the injector and manual subcutaneous administration.

These findings suggest that the delivery method may matter nearly as much as the medicine itself for many patients. Cancer treatment can be tiring, stressful, and time-consuming. A method that reduces time in care settings and offers more flexibility may support a better overall treatment experience.

Impact on Sanofi’s Oncology Strategy

For Sanofi, the approval strengthens its position in oncology and in the competitive multiple myeloma market. Sarclisa-based regimens have been prescribed to nearly 70,000 patients worldwide, and the medicine is approved in almost 60 countries across several indications.

The decision also shows Sanofi’s focus on improving drug delivery, not only drug discovery. By pairing Sarclisa with an on-body injector, the company is trying to make treatment more practical for patients and healthcare systems. This may help reduce pressure on clinics, support outpatient care, and open the door for more patient-centered cancer treatment models.

Regulatory Outlook Beyond Europe

Sanofi has also submitted Sarclisa subcutaneous for review in other major markets, including the United States, China, and Japan. In the United States, the FDA extended its target action date for the Sarclisa subcutaneous application to July 23, 2026.

If approved in more regions, Sarclisa subcutaneous could become a broader global option for multiple myeloma treatment. However, approval timelines and final labeling may vary by country. Patients should always follow guidance from their doctors and local health authorities.

Conclusion

Sanofi’s EU approval for subcutaneous Sarclisa is a notable milestone in multiple myeloma care. It combines an established anti-CD38 therapy with a more flexible method of delivery through an on-body injector. The approval may reduce treatment burden, support outpatient or home-based administration where allowed, and give healthcare providers another option for managing a complex blood cancer. For patients, caregivers, and clinicians, this development points toward a future where cancer care may become not only more effective, but also more convenient and patient-focused.

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