US FDA Has History Of Pushing Sponsors On Confirmatory Trials … Sometimes

 
• By Sue Sutter
  
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Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.

Some FDA review divisions have shown they can push sponsors hard on initiating and completing confirmatory trials. • Source: Shutterstock

In early November, ADC Therapeutics SA made headlines by announcing it would not file for accelerated approval of camidanlumab tesirine for Hodgkin’s lymphoma in 2023 because the US Food and Drug Administration provided “strong guidance” that a randomized, confirmatory study must be well underway, and ideally fully enrolled, at the time of application submission.

During a third quarter earnings call, Regeneron Pharmaceuticals, Inc. fielded a question about the company’s non-Hodgkin’s lymphoma candidate odronextamab,...

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