EU Approves First "On-Body" Cancer Treatment for Multiple Myeloma

In a major paradigm shift for oncology, the European Commission has officially approved the first-ever "on-body" cancer treatment. The decision greenlights the subcutaneous (SC) formulation of Sanofi’s Sarclisa (isatuximab), making it the first anticancer therapy in the European Union to be administered via a wearable, on-body injector (OBI) for patients fighting multiple myeloma.

This regulatory milestone effectively untethers vulnerable cancer patients from hours in hospital infusion chairs, opening the door for hands-free, flexible administration in outpatient clinics or even the comfort of their own homes.

Evolving the Patient Experience
Multiple myeloma is a complex, currently incurable blood cancer affecting bone marrow plasma cells. For years, standard treatments have forced patients into demanding schedules of repeated, prolonged hospital visits for intravenous (IV) infusions.

The newly approved delivery system utilizes the CirCLIQ® OBI, a small, lightweight device that adheres to the skin. At the push of a button, it delivers a fixed dose of the medication through a hidden, retractable needle.

"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," said Dr. Mohamad Mohty, Head of the Clinical Hematology and Cellular Therapy Department at Saint-Antoine Hospital in Paris. "There has been a need for innovative approaches to ease this aspect of the treatment journey."

Proven Efficacy, Less Time in the Chair
The European approval spans all currently authorized indications for Sarclisa's intravenous version—covering both newly diagnosed and relapsed or refractory cases.

The approval was heavily anchored by data from the pivotal Phase 3 IRAKLIA study, which pitted the new on-body device directly against traditional IV administration. The results demonstrated clear benefits:

Clinical Non-Inferiority: The on-body injection achieved a 71.1% objective response rate (ORR) when combined with standard therapy, virtually identical to the 70.5% ORR seen in the IV group.

Drastic Reduction in Reactions: Infusion-related side effects plummeted. Only 1.5% of patients using the on-body device experienced reactions, compared to a staggering 25% of patients in the IV arm.

High Patient Satisfaction: Over 70% of patients treated via the wearable injector reported being highly satisfied with their experience, compared to just 53.4% of those receiving the standard IV.

Delivery Method Objective Response Rate (ORR) Infusion-Related Reaction Rate
Sarclisa On-Body Injector (SC) 71.1% 1.5%
Sarclisa Intravenous (IV) 70.5% 25.0%
A New Frontier for Cancer Care
By shifting care away from traditional oncology wards, healthcare systems across Europe stand to free up critical clinic workflows and nursing resources. Sanofi’s Global Head of Oncology, Olivier Nataf, emphasized that the ultimate goal of the device is "grounded in real-world impact," marrying a well-established safety profile with unprecedented "convenience, flexibility, and accessibility."

With this approval, Sarclisa becomes the only anti-CD38 monoclonal antibody in Europe that gives healthcare providers and patients the dual choice of manual subcutaneous injections or the fully automated on-body device. Rollout across EU member states is expected to begin in the coming months.