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BioWorld - Wednesday, May 14, 2025
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Home » Is 20+ years too long for a confirmatory trial? ODAC to weigh in
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Is 20+ years too long for a confirmatory trial? ODAC to weigh in

Nov. 14, 2023
By Mari Serebrov
If everything goes according to the current plan, the U.S. FDA would get the final report of a confirmatory trial for Acrotech Biopharma Inc.’s Folotyn (pralatrexate) and Beleodaq (belinostat) in 2030 – more than two decades after Folotyn received accelerated approval to treat relapsed or refractory peripheral T-cell lymphoma and 16 years after Beleodaq was granted accelerated approval for the same indication.
BioWorld Regulatory Cancer U.S. FDA

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