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Confirmatory Trials: Comprehensive Development Plan, Early Communication Will Help Reduce Delays, US FDA Says

 
• By Sue Sutter

Accelerated approval sponsors who want to demonstrate due diligence in conducting confirmatory trials should bring a comprehensive program for verifying benefit to the agency early and be proactive in communicating about challenges that could lead to delays, FDA’s oncology review staff say at an adcomm on delayed trials for Acrotech’s lymphoma drugs.  

Hockey net
A comprehensive development plan may provide an opportunity for multiple shots on goal when it comes to confirming an accelerated approval drug's clinical benefit. • Source: Shutterstock

Accelerated approval sponsors who want to demonstrate due diligence in conducting confirmatory trials should bring a comprehensive program for verifying clinical benefit to the US Food and Drug Administration early in development and be proactive in communicating with agency staff about challenges that could lead to study delays.

Key Takeaways

  • Sponsors should come to the FDA with a comprehensive program for verifying clinical benefit, potentially including multiple confirmatory trials.

  • Sponsors also should notify the agency promptly if they start to run into problems that could threaten timely accrual and completion of the studies

Those were some key takeaways from a recent Oncologic Drugs Advisory Committee review of two Acrotech Biopharma LLC drugs with long overdue confirmatory trial requirements

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