Posted by Michael Wonder on 11 Jul 2026
FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
10 July 2026 - On 9 July 2026, the FDA approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis) for subcutaneous injection for multiple myeloma indications.
Efficacy of isatuximab-irfc administered subcutaneously in combination with pomalidomide and dexamethasone was evaluated in an open-label non-inferiority trial, IRAKLIA, randomizing 531 patients (1:1) to receive either isatuximab-irfc administered subcutaneously with the on-body delivery system or intravenous isatuximab-irfc, in combination with pomalidomide and dexamethasone.
