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FEBRUARY 26, 2024

FDA Issues Final Decision to Withdraw Approval of Pepaxto for Multiple Myeloma


Originally published by our sister publication Clinical Oncology News

The FDA has announced its final decision to withdraw approval of melphalan flufenamide (Pepaxto, Oncopeptides), which was being used under an accelerated approval for use in combination with dexamethasone to treat certain patients with multiple myeloma.     

The agency determined the following grounds for withdrawal were met:
     —The confirmatory study conducted as a condition of accelerated