French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Friday that the US Food and Drug Administration (FDA) has approved the company's subcutaneous Sarclisa (isatuximab-irfc) Escena for use in combination with standard-of-care regimens across all existing indications of the intravenous formulation for multiple myeloma.

This approval makes Sarclisa Escena the first anticancer therapy available through both an on-body injector and manual subcutaneous administration in the United States.

The decision was supported by multiple studies, including the phase 3 IRAKLIA non-inferiority trial, which showed subcutaneous administration via an on-body injector delivered efficacy, pharmacokinetics and safety comparable to intravenous infusion while reducing treatment time and infusion-related reactions. In the study, Sarclisa SC with pomalidomide and dexamethasone achieved a 71.1% objective response rate versus 70.5% for the intravenous regimen, meeting the trial's non-inferiority endpoint.

The studies used Enable Injections' hands-free CirCLIQ on-body injector, developed using the enFuse platform, with the device designed to simplify administration and reduce the physical burden on healthcare providers while allowing greater patient monitoring. The overall safety profile was consistent with the intravenous formulation, while systemic administration reactions were reported in 1.5% of patients receiving the subcutaneous regimen compared with 25% for the intravenous regimen. Injection site reactions occurred in 0.4% of on-body injector administrations.

Sarclisa is approved in the US across three multiple myeloma indications, including newly diagnosed patients not eligible for autologous stem cell transplant and relapsed or refractory patients receiving approved combination regimens.