The FDA has approved a subcutaneous (under-the-skin) formulation of isatuximab-irfc (Sarclisa Escena) for all indications previously covered by the intravenous (IV) version in multiple myeloma. The treatment can be administered using the wearable CirCLIQ on-body delivery system or a manual syringe, making it the first FDA-approved cancer therapy delivered through an on-body injector.
The approval is supported by results from the phase 3 IRAKLIA trial, which showed that the subcutaneous formulation was as effective as the IV version. Overall response rates were 71.1% with subcutaneous isatuximab and 70.5% with IV treatment, while very good partial response or better rates were nearly identical.
The subcutaneous version also reduced infusion-related reactions, with rates of 1.5% compared with 25.0% for IV therapy. Overall side effects, serious adverse events, and treatment discontinuation rates were similar between groups, while device-related side effects occurred in 3.4% of patients using the wearable injector.