FDA Panel To Consider Strategies For Timely Completion Of Accelerated Approval Confirmatory Trials

15 Nov 2023

Confirmatory trials for anti-cancer drugs should be targeted for completion no later than two to four years after accelerated approval is granted, agency says, offering various strategies and factors sponsors should consider to ensure they are conducting studies with due diligence.

Hammer — FDA may be more willing to bring down the hammer on oncology accelerated approval drug sponsors who fail to conduct their confirmatory trials with due diligence. • Source: Shutterstock

A US Food and Drug Administration advisory committee review of two Acrotech Biopharma LLC accelerated approval drugs with long-overdue confirmatory trial requirements may provide the clearest insight yet into how the Oncology Center of Excellence interprets the “due diligence” requirement for such studies and how sponsors’ planning and implementation strategies may factor into this determination.

The Oncologic Drugs Advisory Committee on 16 November will not only review Acrotech’s current confirmatory trial plan for the peripheral T-cell lymphoma drugs Folotyn (pralatrexate) and Beleodaq (belinostat), but it...

FDA Panel To Consider Strategies For Timely Completion Of Accelerated Approval Confirmatory Trials

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