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
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