Sanofi has received regulatory approval in the US for Sarclisa Escena (isatuximab) subcutaneous formulation, the world's first anticancer agent administrable via a wearable on-body injector (OBI), covering all existing indications of intravenous Sarclisa for multiple myeloma (MM). The approval rests on the Phase III IRAKLIA non-inferiority trial, which showed the subcutaneous OBI regimen achieved a 71.1% objective response rate (ORR) versus 70.5% for intravenous delivery, with infusion-related adverse events dropping from 25% to 1.5% and only mild injection-site reactions.

The CirCLIQ OBI, developed on Enable Injections' enFuse platform, enables hands-free automated delivery with a retractable 30-gauge needle, markedly shortening treatment time and enhancing patient convenience.

Sarclisa Escena is now the only US-approved MM therapy offering both wearable injector and manual subcutaneous administration, potentially reshaping subcutaneous drug delivery models in haematology-oncology. By reducing infusion burden and safety risks relative to intravenous dosing, Sanofi aims to differentiate isatuximab in a crowded CD38 market and improve adherence across relapsed or refractory settings.