FDA Approves Sanofi's Sarclisa Escena as First Anticancer Drug Delivered via Wearable On-Body Injector
The FDA cleared a subcutaneous, wearable-device formulation of Sanofi's multiple myeloma drug Sarclisa, the first cancer therapy approved for on-body injector delivery.
Overview
The U.S. Food and Drug Administration approved a subcutaneous formulation of Sanofi’s multiple myeloma drug Sarclisa on July 9, 2026, clearing isatuximab-irfc, marketed as Sarclisa Escena, for delivery through a wearable on-body injector, according to the FDA. Sanofi announced the approval a day later, calling it the first anticancer treatment ever cleared for administration through an on-body injector, according to Sanofi’s press release.
What We Know
The approval covers isatuximab-irfc administered subcutaneously through the CirCLIQ on-body injector, a device made by Cincinnati-based Enable Injections using its enFuse platform, or through manual subcutaneous injection with a syringe and infusion set, according to the FDA. The device is an automated, hands-free injector that delivers high-volume medicines subcutaneously at the push of a button, using a retractable 30g needle that is shorter and thinner than needles typically used for large-volume injections, according to Sanofi. The recommended dose is 1,400 mg, according to the FDA.
The agency approved three specific combination regimens for Sarclisa Escena: with pomalidomide and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor; with carfilzomib and dexamethasone for relapsed or refractory patients who have received one to three prior lines of therapy; and with bortezomib, lenalidomide and dexamethasone for newly diagnosed patients who are not eligible for an autologous stem cell transplant, according to the FDA. Isatuximab-irfc also received orphan drug designation, according to the FDA.
The pivotal evidence came from IRAKLIA (NCT05405166), an open-label, randomized non-inferiority trial that assigned 531 patients with relapsed or refractory multiple myeloma to receive isatuximab-irfc either subcutaneously via the on-body device or intravenously, both alongside pomalidomide and dexamethasone, according to the FDA. The objective response rate was 71.1% (187 of 263 patients) in the subcutaneous arm versus 70.5% (189 of 268 patients) in the intravenous arm, establishing non-inferiority with a relative risk of 1.008 and a 95% confidence interval of 0.903 to 1.126, according to Sanofi. Systemic administration reactions occurred in 25% of patients on the intravenous regimen compared with 1.5% of patients on the subcutaneous regimen, while injection site reactions occurred in 0.4% of on-body injector administrations — 19 of 5,145 injections — with nearly all graded 1, except for one graded 2, according to Sanofi. The most common adverse reactions occurring in at least 20% of patients were upper respiratory tract infection, fatigue, pneumonia, musculoskeletal pain and diarrhea, according to Sanofi.
Two smaller supporting studies backed the other combination regimens. In IZALCO (NCT05704049), a Phase 2 study of 74 patients receiving the subcutaneous formulation with carfilzomib and dexamethasone, the objective response rate was 79.7%, according to the FDA. In IsaSocut (NCT05889221), a single-arm, investigator-sponsored Phase 2 study of 74 newly diagnosed patients ineligible for stem cell transplant receiving the subcutaneous formulation with bortezomib, lenalidomide and dexamethasone, the objective response rate was 97.3%, according to the FDA.
Sikander Ailawadhi, professor of medicine in the Division of Hematology/Oncology at Mayo Clinic Florida and principal investigator of the IRAKLIA study, said in Sanofi’s release: “Treatment administration can be a cumbersome experience for patients, while also placing a strain on providers by requiring physical effort to push high-resistance syringes for several minutes.” He added: “The comparable efficacy observed across multiple studies and the patient-centric design of the OBI offers an opportunity to impact the patient experience while upholding Sarclisa’s consistent efficacy,” according to Sanofi.
Manuela Buxo, Sanofi’s executive vice president and head of specialty care, said: “More than 70,000 patients worldwide have benefitted from Sarclisa, delivering predictable and important efficacy and safety across multiple combinations and lines of therapy.” She added that the company was “proud to bring innovation that will empower physicians to enhance the treatment experience for patients, offering greater simplicity, flexibility and convenience,” according to Sanofi. Donna D. Catamero, associate director of myeloma research and a nurse leadership board member at the International Myeloma Foundation, said the device “has the potential to meaningfully reduce administrative burden, simplifying how therapy is delivered and giving healthcare teams more capacity to focus on their patients,” according to Sanofi.
Sarclisa, an anti-CD38 monoclonal antibody, has been approved in almost 60 countries across four indications, and Sarclisa-based regimens have been prescribed to more than 70,000 patients worldwide, according to Sanofi. The subcutaneous formulation is also approved in the European Union and the United Kingdom, and is approved in Japan for manual injection, with a separate regulatory submission for the on-body injector still under review there, according to Sanofi.
What We Don’t Know
Neither the FDA nor Sanofi has published an exact injection-time figure comparing the on-body device to a standard infusion; both describe the subcutaneous route only as offering a “significantly shorter treatment time,” according to Sanofi. Pricing, insurance coverage details, and the timeline for the device’s rollout to infusion centers and pharmacies have not yet been disclosed in the sources reviewed. It also remains to be seen how quickly providers will shift existing intravenous patients to the new subcutaneous, wearable-device option, and whether the on-body injector will affect access for patients who currently self-administer manual subcutaneous injections.
Analysis
The approval extends a broader industry shift toward subcutaneous cancer therapies designed to reduce time spent in infusion chairs, but Sarclisa Escena is notable for pairing that shift with a wearable, automated device rather than a manual injection alone. The IRAKLIA trial’s non-inferiority finding — nearly identical response rates between the on-body injector and intravenous arms, alongside a steep drop in systemic administration reactions — gives the FDA a direct efficacy-and-safety comparison to lean on, rather than requiring providers to extrapolate from separate studies. Whether the device meaningfully changes treatment patterns will likely depend on factors the current sources do not address, including cost, insurer reimbursement, and how readily oncology practices adopt a new delivery hardware platform alongside an already-established drug.