USFDAJul 17, 2026, 06:07 AM
Sanofi's Sarclisa Escena with on-body injector approved by US FDA
AI Summary
Sanofi announced that the US Food and Drug Administration (FDA) has approved subcutaneous (SC) Sarclisa Escena for the treatment of multiple myeloma (MM) across all existing indications of its intravenous (IV) formulation. This marks the first anticancer treatment to be administered through an on-body injector (OBI), offering a more convenient and patient-centric treatment experience. The approval was supported by the IRAKLIA phase 3 study, which demonstrated similar efficacy, pharmacokinetics, and safety compared to IV infusion, alongside significantly shorter treatment times and fewer infusion-related reactions.
Key Highlights
- US FDA approved subcutaneous Sarclisa Escena for multiple myeloma (MM) across all existing IV indications.
- Sarclisa Escena is the first anticancer treatment administered via an on-body injector (OBI).
- Pivotal IRAKLIA phase 3 study showed non-inferiority to IV infusion with similar efficacy and safety.
- IRAKLIA study demonstrated 71.1% objective response rate (ORR) for SC vs 70.5% for IV Sarclisa.
- SC administration resulted in significantly shorter treatment time and fewer infusion-related reactions (1.5% vs 25%).
- Injection site reactions (ISRs) occurred in 0.4% of OBI injections, mostly Grade 1.
- Over 70,000 patients worldwide have benefited from Sarclisa.
Price Impact
More from SNY