Pepaxto (melphalan flufenamide) with dexamethasone gained accelerated approval in February 2021, but the therapy failed a confirmatory trial. The manufacturer, Oncopeptides, then suspended enrollment. In July 2021, the FDA said there was a “detrimental effect on overall survival” in the study.
About a year later, an agency committee voted 14-2 in concluding an unsafe benefit-risk ratio. In August 2023, the FDA proposed pulling the approval, and the decision was finalized Feb. 23.
In a news release, the agency said “it is FDA’s understanding that Oncopeptides does not currently market Pepaxto in the U.S.”
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.