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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

Acrotech Biopharma LLC’s current seven-year timeline for confirming clinical benefit of the lymphoma drugs Folotyn (pralatrexate) and Beleodaq (belinostat) under accelerated approval is excessive, and the company should consider additional studies to better clarify the drugs’ efficacy and safety in a shorter period of time, a US Food and Drug Administration advisory committee said.

Specifically, many panelists seemed to favor an idea put forth by Oncology Center of Excellence Director Richard Pazdur for a shorter, smaller study in a refractory population of peripheral T-cell lymphoma patients conducted

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