Confirmatory Trial Plan For Acrotech’s Folotyn, Beleodaq Needs Rethinking, FDA Panel Says

 
• By Sue Sutter

Seven-year timeline for Phase III trial in first-line peripheral T-cell lymphoma is too long, advisory committee members say, also questioning study feasibility; some panelists favor Richard Pazdur’s push for a second, concurrent trial in the relapsed/refractory setting that could read out sooner.

Baseball plate
Acrotech has a responsibility to step up to the plate and confirm the clinical benefits of its suboptimally developed accelerated approval drugs, FDA's Richard Pazdur said. • Source: Shutterstock

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