FDA Panel To Consider Strategies For Timely Completion Of Accelerated Approval Confirmatory Trials
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.
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Confirmatory Trials: Comprehensive Development Plan, Early Communication Will Help Reduce Delays, US FDA Says
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.
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.
Sponsors needs to think carefully about what to say in product promotions when clinical benefit has not yet been demonstrated, legal and regulatory experts said; such communications may or may not be able to leverage US FDA guidances on ‘consistent with labeling’ (CFL) and scientific information on unapproved uses (SIUU).