Sanofi’s subcutaneous Sarclisa Escena becomes the first anticancer therapy delivered via an on-body injector to win US approval

The US FDA  has recently approved subcutaneous Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens for patients with multiple myeloma across every existing indication of the Sarclisa intravenous formulation. The approval makes Sarclisa Escena the first anticancer treatment to be delivered through both an on-body injector and manual subcutaneous administration.

Supporting evidence for the decision spans several studies, chief among them the pivotal IRAKLIA Phase 3 non-inferiority trial, which confirmed that Sarclisa Escena administered subcutaneously via an on-body injector delivered comparable efficacy, pharmacokinetics, and safety to intravenous infusion, while also meaningfully shortening treatment time and reducing the incidence of infusion-related reactions.

“Multiple myeloma is a malignancy that often requires frequent IV infusions or manual subcutaneous injections. 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,” said Sikander Ailawadhi, MD, Professor of Medicine, Division of Hematology/Oncology at Mayo Clinic Florida, and principal investigator of the IRAKLIA study. “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.”

The studies made use of Enable Injections’ hands-free on-body injector, an automated device engineered to subcutaneously deliver high-volume medicines at the push of a button. The device incorporates a retractable 30-gauge needle that is notably shorter and finer than those typically associated with large-volume injections. The approval of Sarclisa Escena with Enable Injections’ CirCLIQ on-body injector, developed on the enFuse platform, carries the potential to meaningfully reshape the overall treatment experience for people living with multiple myeloma.

“Sarclisa is the cornerstone of our oncology franchise, and we have always been confident in it being widely adopted as a potential best-in-class therapy,” said Manuela Buxo, Executive Vice President, Head of Specialty Care at Sanofi. “The approval of Sarclisa Escena subcutaneous formulation administered with the CirCLIQ is a definitive step in this direction. More than 70,000 patients worldwide have benefitted from Sarclisa, delivering predictable and important efficacy and safety across multiple combinations and lines of therapy. Today, we are proud to bring innovation that will empower physicians to enhance the treatment experience for patients, offering greater simplicity, flexibility and convenience.”

The CirCLIQ device may also ease the administrative workload for healthcare teams, offering a hands-free approach that could reduce the physical demands placed on nursing staff while freeing up time and attention for patient monitoring and direct care.

“The introduction of Sarclisa Escena with the innovative CirCLIQ on-body injector represents a significant advancement in multiple myeloma care,” said Donna D. Catamero, ANP-BC, OCN, CCRC, Associate Director, Myeloma Research, Adjunct Faculty at Mount Sinai Phillips School of Nursing, and International Myeloma Foundation Nurse Leadership Board member. “For nurses and physicians treating patients with multiple myeloma, this automated system has the potential to meaningfully reduce administrative burden, simplifying how therapy is delivered and giving healthcare teams more capacity to focus on their patients.”

Within the IRAKLIA Phase 3 study, the first trial ever to incorporate an on-body injector in multiple myeloma treatment, Sarclisa SC delivered via an on-body injector alongside pomalidomide and dexamethasone achieved an objective response rate of 71.1%, set against 70.5% for Sarclisa intravenous with the same regimen, confirming non-inferiority in adults with relapsed or refractory multiple myeloma who had received at least one prior treatment line.

The safety characteristics of Sarclisa SC combined with pomalidomide and dexamethasone were consistent with the established profile of the intravenous combination. Systemic administration reactions arose in 25% of those on the intravenous regimen, falling sharply to 1.5% among those receiving the subcutaneous version. No previously unidentified safety concerns emerged, aside from injection site reactions in 0.4% of on-body injector administrations, nearly all of which were grade 1 in severity, with a single grade 2 episode noted.

The most frequently occurring adverse reactions, each affecting at least 20% of patients, were upper respiratory tract infection, fatigue, pneumonia, musculoskeletal pain, and diarrhoea. Among haematology laboratory abnormalities arising in at least 40% of patients were decreases in leukocytes, neutrophils, lymphocytes, platelets, and haemoglobin.

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FDA Approval, Sanofi, sanofi sarclisa, Sarclisa®