5 minOn July 10, 2026, Sanofi announced that the U.S. Food and Drug Administration (FDA) has officially approved the subcutaneous formulation Sarclisa Escena (isatuximab-irfc) for the treatment of patients with multiple myeloma (MM), covering all indications currently approved for the intravenous (IV) version of Sarclisa.
This approval not only marks Sarclisa’s transition into the era of subcutaneous therapy but also sets a major industry milestone: Sarclisa Escena is the world's first anticancer treatment to be administered via an On-Body Injector (OBI). It is also the first multiple myeloma therapy in the U.S. to offer the flexibility of both automated "on-body" delivery and manual subcutaneous injection.
A Paradigm Shift in Treatment: From IV Infusions to "One-Click" Wearable Delivery
Multiple myeloma patients often face years of intensive treatment. Conventional intravenous (IV) infusions or manual subcutaneous injections not only require frequent hospital visits but, due to the high viscosity of monoclonal antibodies, manual administration can place a significant physical burden on healthcare providers while requiring prolonged treatment times.
Sarclisa Escena, used in conjunction with the CirCLIQ® On-Body Injector (OBI), fundamentally transforms this experience. Developed by Sanofi in collaboration with Enable Injections and based on the enFuse® technology platform, the system utilizes a micro-sized 30g needle. Patients or caregivers can initiate high-volume subcutaneous delivery with the simple push of a button. This "hands-free" design significantly shortens administration time, liberating medical staff from the physical strain of manual pushing and allowing them to focus on real-time patient monitoring and supportive care.
The IRAKLIA Phase 3 Study: Efficacy and Safety Validated
The approval of Sarclisa Escena is supported by multiple clinical studies, most notably the pivotal IRAKLIA Phase 3 trial, which was the first to incorporate the use of an OBI in the treatment of multiple myeloma. The results demonstrated that when treating adult patients with relapsed or refractory multiple myeloma (R/R MM) who had received at least one prior line of therapy, Sarclisa Escena performed on par with the IV formulation:
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Equivalent Clinical Efficacy: When combined with pomalidomide and dexamethasone (Pd), Sarclisa Escena achieved an objective response rate (ORR) of 71.1% (187/263), compared to 70.5% (189/268) for the Sarclisa IV-Pd group, demonstrating non-inferiority (relative risk 1.008; 95% CI: 0.903-1.126).
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Significantly Improved Safety Profile: Sarclisa Escena demonstrated a clear safety advantage. Among patients treated with Sarclisa IV-Pd, 25% experienced systemic administration reactions; this figure dropped to just 1.5% in the Sarclisa SC-Pd group.
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Low Injection Site Reaction (ISR) Rates: Across more than 5,145 OBI injections, the incidence of ISRs was exceptionally low (only 0.4%), with nearly all events classified as mild (Grade 1).
Redefining Quality of Life Through Flexible Administration
Sarclisa Escena is not only the first anticancer therapy delivered via an OBI, but it is also the only anti-CD38 monoclonal antibody in the U.S. to provide the flexibility of both automated OBI delivery and manual subcutaneous administration. This dual-track approach offers doctors and patients unprecedented flexibility, allowing treatment paths to be tailored to specific clinical environments and individual patient needs.
"More than 70,000 patients worldwide have already benefited from the consistent efficacy of Sarclisa," said Manuela Buxo, Executive Vice President and Head of Specialty Care at Sanofi. "The approval of Sarclisa Escena marks a definitive step in our sprint toward the goal of providing best-in-class therapy."
Industry Impact: Reducing the Burden of Care
"For the nursing and medical teams treating multiple myeloma patients, this automated system substantially reduces the administrative and operational burden," noted Donna D. Catamero, an expert in myeloma research. "When technology simplifies the mechanics of drug delivery, it frees up healthcare teams to focus on their patients, improving the quality of clinical interaction."
Sarclisa is currently approved for multiple indications in the U.S., spanning both newly diagnosed (NDMM) and relapsed/refractory (R/R MM) settings. With the broad commercial availability of Sarclisa Escena in the U.S., Sanofi has further solidified its leadership in oncology—not just through molecular innovation, but through a human-centric evolution of the care experience. For the tens of thousands of patients living with multiple myeloma, this represents more than just a simpler treatment process; it signifies a new era of dignified, flexible, and sustainable disease management.
