EU Commission Expands Pepaxti Approval for Multiple Myeloma Patients

The European Commission has approved an expanded label for Pepaxti (melphalan flufenamide) in treating adult multiple myeloma patients. This approval now includes those who have undergone at least two prior therapies and are refractory to lenalidomide and their last treatment line. This regulatory decision, confirming an EMA opinion, removes the triple-class refractoriness requirement, potentially doubling the eligible patient population in Europe.