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BioWorld - Wednesday, December 17, 2025
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Home » FDA alert renews concerns about Oncopeptides’ Pepaxto
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FDA alert renews concerns about Oncopeptides’ Pepaxto

July 28, 2021
By Mari Serebrov
Another shoe dropped on Oncopeptides AB when the U.S. FDA issued an alert July 28 citing trial data showing an increased risk of death with the company’s only marketed drug, Pepaxto, used in combination with dexamethasone to treat multiple myeloma. The agency said it’s continuing to evaluate the Ocean trial results and may hold a public meeting to discuss the safety findings and explore the continued marketing of Pepaxto (melphalan flufenamide), which was granted accelerated approval in February as a fifth-line treatment for relapsed or refractory multiple myeloma.
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