The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of a subcutaneous formulation of Sanofi’s Sarclisa (isatuximab) for treating multiple myeloma across all currently approved indications for the intravenous version. If approved, Sarclisa would become the first anticancer treatment available through both an on-body injector and manual injection, and the only anti-CD38 monoclonal antibody in multiple myeloma to offer both delivery methods.
The recommendation is based on positive results from the Phase 3 IRAKLIA study in relapsed or refractory multiple myeloma, plus four supporting studies demonstrating comparable efficacy, pharmacokinetics, and safety between subcutaneous and intravenous administration. The enFuse On-Body Injector uses a thinner, retractable needle designed to enhance patient comfort, and patient satisfaction studies showed greater preference for the on-body injector compared to intravenous administration.
The subcutaneous formulation is expected to reduce the time patients spend in treatment centers and improve the overall treatment experience for people living with multiple myeloma.