23 February 2024 - Today, the FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma.

The agency determined the following grounds for withdrawal were met: (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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