Sanofi Grabs Approval for First Wearable Subcutaneous Cancer Therapy in US

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.

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