Sanofi Announces Positive Opinion Recommendation From European Medicines Agency's Committee For Medicinal Products For Human Use For Sarclisa Subcutaneous In Combination With Approved Standard-Of-Care Regimens For Patients With Multiple Myeloma

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Sanofi's Sarclisa (isatuximab) subcutaneous formulation for treating multiple myeloma. If approved, Sarclisa would be the first anticancer treatment available for administration via both an on-body injector and manual injection, and the only anti-CD38 monoclonal antibody in multiple myeloma to offer this flexibility. A final decision on the approval is anticipated in the coming months.