Boston, USA; Sanofi has achieved a major milestone in cancer treatment after the U.S. Food and Drug Administration (FDA) approved Sarclisa Escena, a new subcutaneous version of its multiple myeloma therapy that can be delivered through an innovative on-body injector (OBI). The approval marks the first time an anticancer treatment can be administered using this wearable technology, opening a new chapter in how patients receive therapy.

For many people living with multiple myeloma, treatment often means spending hours in infusion centers receiving intravenous (IV) medicines or undergoing lengthy manual injections. These repeated hospital visits can be physically and emotionally exhausting, especially for patients who require long-term therapy.

Sanofi's newly approved Sarclisa Escena is designed to change that experience. Instead of a traditional IV infusion, the medicine is delivered just beneath the skin using the CirCLIQ on-body injector, a hands-free wearable device developed with Enable Injections' enFuse platform. The injector allows the treatment to be administered automatically after activation, reducing the need for prolonged manual procedures.

The FDA approval covers all currently approved indications of intravenous Sarclisa in the United States. This means eligible patients with newly diagnosed or relapsed and refractory multiple myeloma can now receive the same therapy through a more convenient subcutaneous option without compromising treatment effectiveness.

The decision was based on results from the pivotal IRAKLIA Phase 3 clinical trial, where researchers compared the wearable injector with the traditional IV formulation. The study demonstrated that patients receiving Sarclisa Escena achieved nearly identical treatment outcomes while benefiting from significantly shorter administration times.

The trial reported an objective response rate of 71.1% for patients treated with the subcutaneous formulation, compared with 70.5% for those receiving intravenous therapy. These findings confirmed that the new delivery method was not inferior to the existing IV treatment while maintaining similar pharmacokinetics and overall safety.

Researchers also observed a meaningful improvement in treatment tolerability. While around 25% of patients receiving intravenous Sarclisa experienced infusion-related reactions, only 1.5% of patients using the subcutaneous version reported similar reactions. Injection-site reactions remained uncommon, occurring in only 0.4% of more than 5,000 injections, with almost all cases being mild.

Beyond patient benefits, healthcare professionals believe the technology could improve hospital workflows. Nurses no longer need to manually administer high-resistance injections for several minutes, allowing them to spend more time monitoring patients and providing supportive care instead of focusing solely on the injection process.

Dr. Sikander Ailawadhi, principal investigator of the IRAKLIA study, noted that multiple myeloma treatment often demands frequent hospital visits and lengthy administration procedures. He explained that combining proven clinical effectiveness with a patient-friendly wearable device could significantly improve the overall treatment experience while maintaining confidence in therapy outcomes.

Healthcare experts also see practical advantages for busy oncology centers. Donna D. Catamero, a multiple myeloma nursing specialist, said the automated system could reduce the administrative burden on healthcare teams, simplify treatment delivery, and create more opportunities for nurses and physicians to focus directly on patient care.

Sarclisa has become one of Sanofi's leading oncology medicines and has already been used to treat more than 70,000 patients worldwide. The company believes offering both wearable and manual subcutaneous administration provides greater flexibility for physicians while giving patients more treatment options based on individual needs and clinical settings.

The approval also reflects a broader shift in cancer care toward treatments that improve convenience without sacrificing effectiveness. As healthcare systems continue to seek ways to reduce hospital time and enhance patient comfort, wearable drug delivery technologies like the CirCLIQ on-body injector could play an increasingly important role in future oncology practice.

About Sanofi

Sanofi is a global healthcare company focused on developing innovative medicines and vaccines across oncology, immunology, rare diseases, neurology, and other therapeutic areas. The company invests heavily in research to improve patient outcomes through advanced science and modern treatment technologies. In oncology, Sanofi continues to expand its portfolio with therapies designed to make cancer treatment more effective, accessible, and convenient for patients worldwide.

Resources:

https://www.sanofi.com/en/media-room/press-releases/2026/2026-07-10-12-35-09-3325483

https://www.towardshealthcare.com/insights/physician-practice-management-market-sizing

https://www.towardshealthcare.com/