FDA Approves First On-Body Injector Cancer Therapy: Sanofi’s Sarclisa Escena

On July 10, 2026, the U.S. Food and Drug Administration granted approval for Sarclisa Escena (isatuximab-irfc), a subcutaneous formulation of Sanofi’s multiple-myeloma antibody Sarclisa. The drug can be administered either by manual subcutaneous injection or through the CirCLIQ on-body injector (OBI), a wearable device attached to the skin. The approval covers all existing U.S. indications for the intravenous (IV) version of Sarclisa, extending its use to patients with relapsed or refractory multiple myeloma and newly diagnosed patients who are ineligible for stem-cell transplant.

FDA approves Sarclisa Escena, first anticancer ...Press Release: Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injectorBenzingaNewsmax (website)ReutersSubcutaneous Sarclisa Escena Receives FDA Nod for Multiple Myeloma

Sarclisa, a CD38-directed cytolytic antibody, received its initial FDA approval in 2020 for IV infusion in relapsed multiple myeloma. Sanofi introduced the subcutaneous version to address the lengthy (up to three-hour) infusion process and the physical burden on oncology nurses. The on-body injector, developed by Enable Injections using the enFuse platform, employs a retractable 30-gauge needle designed for high-volume subcutaneous delivery with a single button press.

Reuters

The pivotal Phase 3 IRAKLIA trial (NCT05405166) randomized 531 adults who had received at least one prior therapy to receive pomalidomide + dexamethasone combined with either Sarclisa Escena 1,400 mg SC via OBI (n = 263) or the standard IV dose (n = 268). The study met its non-inferiority endpoint, showing an objective response rate (ORR) of 71.1 % versus 70.5 % for IV therapy. Pharmacokinetic analysis reported a geometric-mean steady-state C_trough ratio of 1.53 (90 % CI 1.32-1.78). Systemic administration reactions dropped from 25 % with IV to 1.5 % with SC, while injection-site reactions occurred in only 0.4 % of OBI administrations (19 of 5,145 injections). Additional Phase 2 studies (IZALCO, IsaSocut) demonstrated ORRs of 79.7 % (carfilzomib + dexamethasone) and 97.3 % (bortezomib + lenalidomide + dexamethasone) in smaller cohorts.

Subcutaneous Sarclisa Escena Receives FDA Nod for Multiple Myeloma

The on-body injector reduces median administration time to roughly 13 minutes, compared with up to three hours for IV infusion, easing clinic workflow and nurse workload. Sanofi lists the SC vial with OBI at $8,796 per dose, whereas the IV vial ranges from $956.10 to $4,780.54. In 2025, Sarclisa generated €588 million ($671.7 million) in sales; analysts project €710 million in 2026. The approval also supports CEO Belén Garijo’s strategy to diversify revenue beyond the asthma biologic Dupixent.

Reuters

The FDA highlighted that the approval was based on “robust data demonstrating comparable efficacy, pharmacokinetics and safety to the IV formulation while significantly reducing treatment time and infusion-related reactions.” Sanofi’s press release emphasized that the new delivery option “offers a treatment experience designed with patients and healthcare providers in mind” and may “streamline administration for providers, reducing the physical burden on nurses.”

Reuters

• “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,” — Sikander Ailawadhi, MD, Professor of Medicine, Mayo Clinic Florida

Press Release: Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector

• “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,” — Manuela Buxo, Executive Vice President, Head of Specialty Care, Sanofi

Press Release: Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector

• “The approval of Sarclisa Escena subcutaneous formulation administered with the CirCLIQ is a definitive step in this direction.” — Manuela Buxo, Executive Vice President, Head of Specialty Care, Sanofi

Press Release: Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector

• “The introduction of Sarclisa Escena with the innovative CirCLIQ on-body injector represents a significant advancement in multiple myeloma care,” — Donna D. Catamero, ANP-BC, OCN, CCRC, Associate Director, Myeloma Research, Mount Sinai Phillips School of Nursing

Press Release: Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector

Sanofi plans to market Sarclisa Escena across all approved combination regimens in the United States while pursuing similar regulatory submissions in Japan, where a manual SC version is already approved and an OBI application is under review.

Press Release: Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector