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The Food and Drug Administration (FDA) has made the final decision to withdraw approval of Pepaxto (melphalan flufenamide), a medication previously approved for use in combination with dexamethasone to treat certain patients with multiple myeloma.
The agency cited two primary reasons for this withdrawal. Firstly, the confirmatory study conducted to validate Pepaxto’s clinical benefit, as required for accelerated approval, did not provide the necessary confirmation. Secondly, the available evidence indicates that Pepaxto is not demonstrated to be safe or effective under its conditions of use.
The final decision was issued by Dr. Peter Marks, the Director of the FDA’s Center for Biologics Evaluation and Research, acting as the Commissioner’s designee. Effective immediately, this decision marks the conclusion of the FDA’s review process regarding Pepaxto’s approval status.
In light of this decision, the FDA intends to publish a notice in the Federal Register to formally announce today’s decision and to remove Pepaxto from the Orange Book, which lists approved drug products with therapeutic equivalence evaluations. Notably, the FDA understands that Oncopeptides, the manufacturer of Pepaxto, does not currently market the drug in the United States.
The withdrawal of Pepaxto’s approval underscores the FDA’s commitment to ensuring that medications on the market meet rigorous standards of safety and efficacy. Patients and healthcare providers rely on the FDA’s evaluation process to make informed decisions about treatment options, and the agency remains steadfast in its dedication to upholding public health and safety standards.
