Accelerated Approval Process Is Not Without Risk: Placing Recent FDA Action in Context

On February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for treatment of multiple myeloma. The decision came after a post-marketing, confirmatory study of Pepaxto failed to confirm the drug’s clinical benefit, and FDA determined that available evidence demonstrated that Pepaxto was not shown to be safe or effective under its conditions of use. Although accelerated approval remains an…
By: Troutman Pepper
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