FDA Approves First Wearable On-Body Injector for Cancer Drug Delivery with Sanofi's Sarclisa

Jul 9, 2026

The U.S. FDA has approved Sanofi's Sarclisa Escena, making it the first subcutaneous anticancer drug deliverable via an on-body injector for multiple myeloma. Developed with Enable Injections' CirCLIQ wearable device, the therapy reduces administration times from three hours to a median of 13 minutes. Phase 3 trial data demonstrated equivalent efficacy to intravenous delivery while reducing systemic reactions from 25% to 1.5%, positioning Sanofi to better compete against Johnson & Johnson's Darzalex.

Sarclisa Escena FDA approval

▪The U.S. list price for Sarclisa Escena with the on-body injector is $8,796 per vial, compared to the intravenous form which ranges from $956.10 to $4,780.54 per single-dose vial.
▪Sarclisa Escena is the first subcutaneous anticancer treatment approved by the U.S. Food and Drug Administration that can be administered via an on-body injector or manual subcutaneous injection.
▪The U.S. Food and Drug Administration approved Sanofi's Sarclisa Escena, a subcutaneous formulation of the blood cancer drug Sarclisa, on July 10, 2026.
▪The U.S. Food and Drug Administration approval of Sarclisa Escena covers all existing indications of the drug's intravenous formulation for treating multiple myeloma.

Anti-CD38 therapy market competition

▪Sanofi's Sarclisa competes in the anti-CD38 drug class against Johnson & Johnson's Darzalex, which reached the market in 2015 and gained approval for its subcutaneous version, Darzalex Faspro, in 2020.
▪Sarclisa generated €588 million ($671.67 million) in sales in 2025, while Johnson & Johnson's Darzalex recorded sales of $14.4 billion during the same year.

IRAKLIA phase 3 trial results

▪In the phase 3 IRAKLIA trial, systemic administration reactions occurred in 1.5% of patients in the on-body injector group compared to 25% of patients in the intravenous group.
▪The phase 3 IRAKLIA trial demonstrated that Sarclisa Escena administered via an on-body injector achieved a 71.1% objective response rate, compared to 70.5% for the intravenous formulation.

Healthcare provider workflow benefits

▪The hands-free automated on-body injector is designed to reduce the physical and administrative burden on oncology nurses, allowing more freedom for patient monitoring.
▪The median injection time for the Sarclisa Escena on-body injector is 13 minutes, whereas the intravenous infusion of the drug can take up to three hours.

Enable Injections device technology

▪Sarclisa Escena is delivered using the CirCLIQ hands-free automated device, which is based on Enable Injections' enFuse on-body injector technology.
▪Enable Injections' enFuse device utilizes a retractable 30-gauge needle that is shorter and thinner than needles typically used for large-volume injections.