The FDA on Friday approved Sanofi's (Sanofi (SNY)) subcutaneous version of its multiple myeloma drug Sarclisa, called Sarclisa Escena, for use across all the indications where the intravenous formulation is already approved. The approval covers combination therapy with standard-of-care regimens.

This makes Sarclisa Escena the first anticancer therapy that can be given either through a manual subcutaneous injection or via a hands-free on-body injector. Sarclisa itself is already approved in the U.S. for three different multiple myeloma indications.

Phase 3 Data Supported FDA Decision

The FDA's decision was backed by data from multiple studies, including the pivotal Phase 3 IRAKLIA trial, which was designed to show that the subcutaneous version was not inferior to the IV version. The study found that Sarclisa Escena delivered through an on-body injector produced similar efficacy, pharmacokinetics, and safety to the IV formulation, while significantly cutting treatment time and reducing 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 given 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 the IV version with the same regimen. Those results met the non-inferiority endpoint.

On-Body Injector Designed to Improve Treatment Experience

The studies used Enable Injections' hands-free CirCLIQ on-body injector, which was 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 Sanofi, 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 market data.