The FDA has approved Sanofi’s subcutaneous Sarclisa Escena in combination with standard-of-care regimens for patients with multiple myeloma across all existing indications of the intravenous formulation, making it the first anticancer treatment administered through an on-body injector.
Sarclisa Escena is administered through Sanofi’s on-body injector and is the first multiple myeloma treatment in the U.S. available through both an on-body injector and manual subcutaneous administration, according to a July 10 news release.
The approval was supported by the phase 3 Iraklia trial, which found Sarclisa Escena delivered similar efficacy, pharmacokinetics and safety as the intravenous formulation while reducing treatment time and infusion-related reactions. The objective response rate was 71.1% with subcutaneous Sarclisa plus pomalidomide and dexamethasone, compared with 70.5% for the intravenous regimen. Systemic administration reactions occurred in 1.5% of patients receiving the subcutaneous formulation versus 25% of those receiving intravenous therapy.
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