The U.S. Food and Drug Administration (FDA) pulled its initial approval of Oncopeptides’ Pepaxto (melphalan flufenamide), a medication used in combination with corticosteroid dexamethasone to treat certain multiple myeloma cases.
The final decision to withdraw approval was made on Feb. 23, approximately three years after the drug received accelerated approval for treating patients with multiple myeloma who had received four or more prior lines of therapy and whose cancer had not responded to at least one proteasome inhibitor, immunomodulatory agent, or CD38-directed monoclonal antibody.
