FDA formally pulls Oncopeptides' cancer drug after prolonged back-and-forth
23 Feb 2024
Accelerated ApprovalDrug Approval
More than a year after the FDA called on Oncopeptides to withdraw Pepaxto (melphalan flufenamide), the Swedish company has finally lost its appeal, and the FDA is withdrawing the drug. Pepaxto initially won an accelerated approval in 2021 as a fifth-line therapy for the blood cancer known as multiple myeloma.
In its final decision letter to Oncopeptides, dated Friday, CBER chief Peter Marks
wrote
that the grounds for withdrawing Pepaxto’s approval have been met because: “(1) the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit and (2) the available evidence demonstrates that Pepaxto is not shown to be safe or effective under its conditions of use.”
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