FDA approves Sanofi’s Sarclisa Escena (isatuximab‑irfc), the first U.S. anticancer therapy delivered via on‑body injector, expanding multiple myeloma treatment options with automated subcutaneous administration.
Written By: Meghana Jinka, PharmD
Reviewed By: Pharmacally Editorial Team
The US Food and Drug Administration has approved Sanofi’s Sarclisa Escena (isatuximab-irfc), the subcutaneous formulation of Sarclisa in the United States, in combination with approved standard-of-care regimens for patients with multiple myeloma (MM) across all currently approved indications of intravenous (IV) Sarclisa. The approval makes Sarclisa Escena the first anticancer therapy administered using an on-body injector (OBI) and the first multiple myeloma treatment in the United States available through both automated subcutaneous delivery and manual subcutaneous injection.
The decision was supported primarily by results from the pivotal Phase III IRAKLIA trial (NCT05405166), which showed that Sarclisa Escena administered through the CirCLIQ® on-body injector, developed using Enable Injections’ enFuse® platform, achieved efficacy, pharmacokinetics, and safety comparable to intravenous Sarclisa while substantially reducing treatment administration time and administration-related reactions.
Expanding treatment options in multiple myeloma
Sarclisa Escena is the U.S. brand name for the subcutaneous formulation of isatuximab-irfc, an anti-CD38 monoclonal antibody approved for newly diagnosed and relapsed or refractory multiple myeloma. Patients often require prolonged intravenous infusions or manual subcutaneous injections throughout treatment, creating logistical challenges for both patients and healthcare providers.
The newly approved wearable on-body injector delivers the drug subcutaneously using a retractable 30-gauge needle with automated administration after activation, eliminating the need for prolonged manual syringe injections. The hands-free device may also reduce the physical workload for nursing staff while allowing greater flexibility during patient monitoring.
Supportive evidence from the Phase II IZALCO study (NCT05704049) also showed a strong patient preference for the on-body injector over manual subcutaneous injection, reinforcing the potential convenience benefits of the automated delivery system.
IRAKLIA trial demonstrated non-inferior efficacy
The randomized, open-label Phase III IRAKLIA study compared a fixed 1,400 mg subcutaneous dose of Sarclisa Escena plus pomalidomide and dexamethasone (Pd) delivered through the on-body injector with standard weight-based intravenous Sarclisa plus Pd in adults with relapsed or refractory multiple myeloma who had received at least one prior line of therapy.
The primary efficacy endpoint was met. The objective response rate (ORR) reached 71.1% (187/263) with Sarclisa Escena-Pd compared with 70.5% (189/268) for intravenous Sarclisa-Pd, establishing non-inferiority (relative risk 1.008; 95% CI: 0.903-1.126).
The overall safety profile was consistent with that previously reported for intravenous Sarclisa, and no new safety concerns were identified.
Most common adverse reactions included upper respiratory tract infection, fatigue, pneumonia, musculoskeletal pain, and diarrhea.
Frequent laboratory abnormalities included decreased leukocytes, neutrophils, lymphocytes, platelets, and hemoglobin.
Systemic administration reactions occurred in 1.5% of patients receiving Sarclisa Escena-Pd, compared with 25% in the intravenous group. Injection-site reactions were uncommon, occurring in 0.4% of injections (19 of 5,145), and were almost exclusively Grade 1, with only one Grade 2 event reported.
Clinicians highlight benefits of automated delivery
Sikander Ailawadhi, MD, Professor of Medicine in the Division of Hematology/Oncology at Mayo Clinic Florida and principal investigator of the IRAKLIA study, said the comparable efficacy together with the patient-focused design of the on-body injector could improve the treatment experience while maintaining the established clinical performance of Sarclisa Escena.
Sanofi’s Head of Specialty Care, Manuela Buxo, said more than 70,000 patients worldwide have received Sarclisa-based treatment and described the approval of Sarclisa Escena as an important step toward improving treatment convenience while preserving efficacy across approved combinations and treatment settings.
Donna D. Catamero, ANP-BC, OCN, CCRC, Associate Director of Myeloma Research and member of the International Myeloma Foundation Nurse Leadership Board, added that the automated delivery system could simplify treatment administration and reduce workload for oncology care teams.
Path Forward
Sarclisa Escena is now approved in the United States across all indications of intravenous Sarclisa, including frontline treatment for transplant-ineligible newly diagnosed multiple myeloma and approved relapsed or refractory multiple myeloma settings. The subcutaneous formulation is also authorized in the European Union and the United Kingdom. In Japan, the manual subcutaneous formulation has been approved, while regulatory review of the CirCLIQ on-body injector remains ongoing.
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About the Writer
Meghana Jinka (LinkedIn) is a Pharm.D graduate with a strong interest in clinical pharmacy, clinical research, pharmacovigilance, and medical writing. She has developed expertise in evaluating scientific literature, interpreting clinical data, and communicating complex medical information in a clear and accessible manner. Through clinical training, patient counseling, and healthcare awareness activities, she has gained practical experience in evidence-based medicine and patient-centered care. Passionate about healthcare communication, Meghana is committed to developing accurate, engaging, and evidence-based healthcare documents that support healthcare professionals and the wider community.