Accelerated Approval: US FDA Wants Comprehensive Development Plan From Oncology Sponsors
Cancer drug developers should come to the agency early with a package of clinical trials to support accelerated approval and confirm clinical benefit rather than with plans to sequentially conduct such studies, Oncology Center of Excellence’s Richard Pazdur says; he also suggests closer scrutiny ahead of whether postmarketing trials are being conducted 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.
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.
Oncology Center of Excellence Director Richard Pazdur also says that he will not grant an accelerated approval if the confirmatory trial is not underway, even if the product shows safety and efficacy.