The U.S. Food and Drug Administration (FDA) approved Sanofi's Sarclisa Escena (isatuximab-irfc) for multiple myeloma treatment. This subcutaneous formulation is the first U.S. anticancer treatment delivered via a wearable, on-body injector (OBI). It provides a less burdensome alternative to traditional intravenous infusions.
The approval covers all existing indications of the intravenous Sarclisa version. The FDA based its decision on the IRAKLIA Phase 3 study. This trial demonstrated comparable efficacy and safety between the OBI and IV formulations.
The new delivery method significantly reduces treatment time and results in fewer infusion-related reactions. This patient-centric design aims to decrease time spent in infusion centers. It also reduces the operational strain on healthcare providers.