FDA approved Sarclisa Escena (isatuximab-irfc), a subcutaneous formulation of Sanofi's Sarclisa, for the treatment of multiple myeloma across all existing indications of the intravenous formulation.

The approval makes Sarclisa Escena the first anticancer treatment that can be administered via both an on-body injector and manual subcutaneous injection, a distinction the company says could meaningfully change the patient and provider experience in a disease that typically demands frequent, time-intensive infusions.

What was the approval based on?

The approval was supported by the pivotal Iraklia Phase III non-inferiority study, which evaluated Sarclisa Escena administered subcutaneously via an on-body injector against the standard weight-based intravenous formulation, both in combination with pomalidomide and dexamethasone, in adult patients with relapsed or refractory multiple myeloma who had received at least one prior line of therapy.¹

In the trial, the subcutaneous arm achieved an objective response rate of 71.1% compared to 70.5% in the IV arm, establishing non-inferiority with a relative risk of 1.008 and a 95% confidence interval of 0.903 to 1.126.² The overall safety profile remained consistent with the established profile of the IV formulation.²

Notably, systemic administration reactions occurred in 25% of patients in the IV arm versus just 1.5% in the subcutaneous arm, while injection site reactions occurred in 0.4% of on-body injector administrations and were nearly all grade one. The most common adverse reactions occurring in at least 20% of patients included upper respiratory tract infection, fatigue, pneumonia, musculoskeletal pain and diarrhea.²

"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, professor of medicine in the 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."

What device is behind the delivery?

The on-body injector at the center of the approval is Enable Injections' CirCLIQ device, developed using the enFuse platform.¹ The automated injector is designed to deliver high-volume medicines subcutaneously with the push of a button, using a retractable 30-gauge needle that is shorter and thinner than those typically used for large-volume injections.¹ Patients wear the device on their body during administration, eliminating the need for a clinician to manually push a syringe.

Sanofi and Enable Injections argue the device addresses two pain points simultaneously, patient comfort and nursing burden. Donna Catamero, associate director of myeloma research and adjunct faculty at Mount Sinai Phillips School of Nursing, said the 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."

Sarclisa is now currently approved across three indications in the U.S.: in combination with bortezomib, lenalidomide and dexamethasone for newly diagnosed multiple myeloma patients ineligible for autologous stem cell transplant; in combination with pomalidomide and dexamethasone for relapsed or refractory patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; and in combination with carfilzomib and dexamethasone for patients who have received one to three prior lines of therapy.¹ The subcutaneous formulation is now approved across all three settings.

Manuela Buxo, executive vice president and head of specialty care at Sanofi, framed the approval as a strategic inflection point for the company's oncology business. "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."

Sources

1. Press Release: Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector Sanofi July 10, 2026 https://www.sanofi.com/en/media-room/press-releases/2026/2026-07-10-12-35-09-3325483
2. Press Release: New Sarclisa subcutaneous formulation met co-primary endpoints in the IRAKLIA phase 3 study in multiple myeloma Sanofi January 9, 2025 https://www.sanofi.com/en/media-room/press-releases/2025/2025-01-09-06-00-00-3006798