Sarclisa Escena has officially become the first anticancer treatment in the United States to be administered through an on-body injector, marking a milestone approval for Sanofi and for multiple myeloma patients across the country. The US Food and Drug Administration (FDA) cleared the subcutaneous formulation on July 10, 2026, in combination with standard-of-care regimens, covering every indication already approved for the intravenous (IV) version of Sarclisa (isatuximab-irfc).
The approval means Sarclisa Escena is now the only anti-CD38 monoclonal antibody in multiple myeloma (MM) that can be given two ways: through the CirCLIQ on-body injector (OBI) or via manual subcutaneous injection. For a disease that typically requires frequent, time-consuming infusions, this dual-delivery flexibility is being described by oncologists as a meaningful shift in how care is delivered.
Paris-based Sanofi confirmed that the approval was supported by multiple clinical studies, most notably the pivotal IRAKLIA phase 3 trial, which compared Sarclisa Escena delivered via OBI against the standard IV infusion.
What the IRAKLIA Study Found About Sarclisa Escena
The IRAKLIA study was the first trial to incorporate an on-body injector into multiple myeloma treatment, and its results formed the backbone of the FDA’s decision. Sarclisa Escena, given subcutaneously through the OBI in combination with pomalidomide and dexamethasone (Pd), demonstrated non-inferior efficacy compared with Sarclisa IV-Pd, while significantly cutting treatment time and reducing infusion-related reactions.
| IRAKLIA Study Metric | Sarclisa Escena SC-OBI | Sarclisa IV |
|---|---|---|
| Objective Response Rate (ORR) | 71.1% (187/263) | 70.5% (189/268) |
| Relative Risk (95% CI) | 1.008 (0.903–1.126) | Reference |
| Systemic administration reactions | 1.5% of patients | 25% of patients |
| Injection site reactions (ISRs) | 0.4% of injections (19/5,145) | Not applicable |
| Trial identifier | NCT05405166 | NCT05405166 |
Expert Reaction to the Sarclisa Escena Approval
Sikander Ailawadhi, MD, Professor of Medicine in the Division of Hematology/Oncology at Mayo Clinic Florida and principal investigator of the IRAKLIA study, said multiple myeloma treatment has long placed a burden on both patients and providers. He noted that frequent IV infusions or manual subcutaneous injections can be a difficult experience for patients, while also demanding significant physical effort from providers who must administer high-resistance syringes over several minutes. According to Ailawadhi, the consistent efficacy shown across studies combined with the patient-focused design of the on-body injector gives clinicians a new way to improve the treatment experience without compromising outcomes.
Manuela Buxo, Executive Vice President and Head of Specialty Care at Sanofi, called Sarclisa the cornerstone of the company’s oncology franchise. She said the Sarclisa Escena approval represents a definitive step toward wider adoption of the therapy, pointing out that more than 70,000 patients worldwide have already been treated with Sarclisa-based regimens. Buxo added that the goal now is to give physicians a way to enhance the treatment experience through greater simplicity, flexibility, and convenience.
Donna D. Catamero, ANP-BC, OCN, CCRC, Associate Director of Myeloma Research and a member of the International Myeloma Foundation Nurse Leadership Board, said the introduction of the CirCLIQ on-body injector could meaningfully reduce the administrative burden on nursing staff, freeing up more time for direct patient care.
How the CirCLIQ On-Body Injector Works with Sarclisa Escena
The CirCLIQ device used to deliver Sarclisa Escena was developed by Cincinnati-based Enable Injections, built on the company’s enFuse platform. It is an automated, hands-free wearable injector designed to deliver high-volume subcutaneous medicines with the push of a button, using a retractable 30-gauge needle that is notably shorter and thinner than needles typically used for large-volume injections.
Sarclisa Escena Approved Indications in the US
Sarclisa Escena is not a new drug in itself; it is the subcutaneous version of an isatuximab-irfc regimen already approved across three indications for Sarclisa IV. With this approval, Sarclisa Escena now mirrors that full label.
| Combination Therapy | Patient Population | Prior Treatment Requirement |
|---|---|---|
| Sarclisa Escena + pomalidomide + dexamethasone | Relapsed/refractory multiple myeloma | At least 1 prior line of therapy, including lenalidomide and a proteasome inhibitor |
| Sarclisa Escena + carfilzomib + dexamethasone | Relapsed/refractory multiple myeloma | 1 to 3 prior lines of treatment that did not work or stopped working |
| Sarclisa Escena + bortezomib + lenalidomide + dexamethasone | Newly diagnosed multiple myeloma | Not eligible for autologous stem cell transplant |
Notably, the prior-therapy requirement for the pomalidomide/dexamethasone combination is less restrictive for Sarclisa Escena (one prior line) than for the original IV formulation of Sarclisa, which requires at least two prior therapies in that same combination.
Safety Profile of Sarclisa Escena
Across the studies supporting approval, Sanofi reported that the most common adverse reactions occurring in 20% or more of patients included upper respiratory tract infection, fatigue, pneumonia, musculoskeletal pain, and diarrhea. The most frequent hematology laboratory abnormalities, seen in 40% or more of patients, were decreased leukocytes, neutrophils, lymphocytes, platelets, and hemoglobin.
The FDA also flagged serious risks associated with Sarclisa Escena, including severe allergic reactions, infections, decreased white blood cell counts, risk of new cancers, and interference with blood-type matching tests for at least six months after the last injection. Heart failure has also been reported in patients receiving the carfilzomib and dexamethasone combination. Full prescribing and safety details are available through the FDA’s MedWatch program, where patients and providers can report adverse events directly.
Sarclisa Escena’s Place in the Global Sanofi Oncology Portfolio
Sarclisa in its various formulations has now been approved in nearly 60 countries across four indications for both newly diagnosed and relapsed or refractory multiple myeloma. The subcutaneous formulation, branded Sarclisa Escena in the US, is also approved in the European Union and the United Kingdom. In Japan, the subcutaneous formulation is approved for manual injection only, while a regulatory submission for the CirCLIQ on-body injector remains under review.
Sanofi describes its oncology strategy as centered on developing first-in-class and best-in-class immunological and targeted therapies for cancers with high unmet need. The Sarclisa Escena approval fits into that broader push to expand treatment options for multiple myeloma patients who often cycle through several lines of therapy over the course of their disease.
What Sarclisa Escena Means for Patients Going Forward
For patients living with multiple myeloma, the practical impact of the Sarclisa Escena approval is a shorter, simpler administration process that does not require sitting through an IV infusion. Because the drug can now be given through the CirCLIQ on-body injector or by manual subcutaneous injection, patients and their care teams have more flexibility in choosing an administration method that fits their treatment setting.
