The U.S. Food and Drug Administration (FDA) on Friday approved Sanofi SA’s (NASDAQ:SNY) subcutaneous Sarclisa Escena (isatuximab-irfc) in combination with standard-of-care regimens for multiple myeloma across all approved indications of the intravenous formulation.
The approval makes Sarclisa Escena the first anticancer therapy that can be administered through both an on-body injector (OBI) and manual subcutaneous injection. Sarclisa is currently approved in the U.S. for three multiple myeloma indications.
Phase 3 Data Supported FDA Decision
The FDA based its decision on data from multiple studies, including the pivotal Phase 3 IRAKLIA non-inferiority trial.
The study found that subcutaneous Sarclisa Escena delivered through an OBI produced efficacy, pharmacokinetics, and safety comparable to the intravenous formulation while significantly reducing treatment time and infusion-related reactions.
The IRAKLIA study was the first Phase 3 trial in multiple myeloma to incorporate an on-body injector.
Among adults with relapsed or refractory multiple myeloma who had received at least one prior line of therapy, Sarclisa SC administered with pomalidomide and dexamethasone achieved an objective response rate of 71.1% (187 of 263 patients), compared with 70.5% (189 of 268 patients) for intravenous Sarclisa with the same regimen.
The results met the study’s non-inferiority endpoint.
On-Body Injector Designed To Improve Treatment Experience
The studies used Enable Injections’ hands-free CirCLIQ on-body injector, developed using the enFuse platform.
The device delivers high-volume medicines subcutaneously with the push of a button and uses a retractable 30-gauge needle that is shorter and thinner than those commonly used for large-volume injections.
According to the company, the approval of Sarclisa Escena with the CirCLIQ OBI has the potential to improve the overall treatment experience for patients with multiple myeloma.
The hands-free system may also streamline administration for healthcare providers by reducing the physical demands on nurses while allowing greater flexibility for patient monitoring and interaction.
SNY Price Action: Sanofi shares were down 0.82% at $43.54 at the time of publication on Friday, according to Benzinga Pro data.
Photo by HJBC via Shutterstock
