Posted by Michael Wonder on 28 Mar 2026
Sanofi’s Sarclisa subcutaneous formulation administered via on body injector recommended for EU approval by the CHMP to treat multiple myeloma
27 March 2026 - Recommendation based on positive results demonstrating comparable efficacy, pharmacokinetics, and safety of Sarclisa regimens administered subcutaneously compared to intravenous infusion.
The EMA’s CHMP has adopted a positive opinion recommending the approval of Sarclisa (isatuximab) subcutaneous in combination with approved standard of care regimens for the treatment of patients with multiple myeloma across all currently approved indications for Sarclisa intravenous formulation in the EU.
