PARIS, July 10, 2026
Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Sarclisa Escena® (isatuximab-irfc) for subcutaneous administration in combination with approved standard-of-care regimens for the treatment of multiple myeloma (MM) across all existing indications of intravenous Sarclisa. The approval marks a major milestone in oncology care as Sarclisa Escena becomes the first anticancer treatment approved for administration through an on-body injector (OBI) while also offering the flexibility of manual subcutaneous injection. Delivered using Enable Injections’ CirCLIQ® on-body injector, developed on the enFuse® platform, the new formulation is designed to simplify treatment delivery, reduce administration time, improve convenience for patients, and lessen the physical burden on healthcare professionals while maintaining the proven efficacy and safety profile of intravenous Sarclisa.
Phase 3 IRAKLIA Trial Demonstrated Comparable Efficacy with Improved Treatment Experience
The FDA approval was primarily supported by findings from the Phase 3 IRAKLIA non-inferiority clinical trial, which compared subcutaneous Sarclisa Escena administered via the CirCLIQ on-body injector with the conventional intravenous formulation in adults with relapsed or refractory multiple myeloma (R/R MM) receiving pomalidomide and dexamethasone. The study demonstrated an objective response rate (ORR) of 71.1% for the subcutaneous formulation compared with 70.5% for intravenous therapy, successfully meeting the study’s non-inferiority endpoint. In addition to delivering comparable efficacy, pharmacokinetics, and safety, the subcutaneous formulation significantly shortened treatment administration time and substantially reduced systemic administration reactions. Only 1.5% of patients receiving Sarclisa Escena experienced systemic administration reactions, compared with 25% of patients treated with intravenous Sarclisa, while injection-site reactions remained infrequent and were predominantly mild. These findings support the subcutaneous formulation as an effective alternative that maintains clinical outcomes while improving the overall treatment experience.
CirCLIQ On-Body Injector Simplifies Cancer Treatment Delivery
The newly approved CirCLIQ® on-body injector introduces a novel method of administering high-volume biologic therapies through a hands-free wearable delivery system. Developed using Enable Injections’ enFuse platform, the device utilizes a short, retractable 30-gauge needle and allows automated subcutaneous drug delivery with the press of a button. The wearable injector reduces the need for prolonged intravenous infusions and eliminates the physical effort associated with manually administering high-resistance syringes, providing important workflow advantages for oncology nurses and physicians. Clinical investigators noted that the patient-centered design has the potential to improve convenience, reduce treatment burden, and allow healthcare professionals to devote more attention to patient care rather than manual drug administration. The approval also represents the first use of an on-body injector for an anticancer therapy, establishing a new treatment option that may influence future oncology drug delivery strategies.
Advertisement
Approval Strengthens Sanofi’s Oncology Portfolio in Multiple Myeloma
The FDA decision further expands Sanofi’s oncology franchise and reinforces Sarclisa’s position as a leading anti-CD38 monoclonal antibody for multiple myeloma. Sarclisa-based therapies have now been used in more than 70,000 patients worldwide and are approved across nearly 60 countries for multiple indications in newly diagnosed and relapsed or refractory multiple myeloma. The newly approved Sarclisa Escena provides physicians with greater flexibility by offering both subcutaneous on-body injector and manual injection administration, making it the only anti-CD38 therapy in multiple myeloma currently available in both delivery formats. Sanofi stated that the approval reflects its continued commitment to advancing innovative cancer therapies that improve both clinical outcomes and the treatment experience. By combining established therapeutic efficacy with next-generation drug delivery technology, Sarclisa Escena represents a significant advancement in multiple myeloma care, offering patients and healthcare providers a faster, more convenient, and patient-focused treatment option while supporting ongoing innovation in oncology.
Source: Sanofi, press release
