EMA recommends expansion of melphalan flufenamide (Pepaxti®) marketing authorisation
The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has granted a positive opinion on the application for an extended marketing authorisation (i.e. a license) for melphalan flufenamide (Pepaxti), also called melflufen. Melflufen, in combination with dexamethasone, is currently licenced in the EU for treating myeloma patients who have received at least three prior lines of therapy and are refractory to at least one proteasome inhibitor (such as…