Oncology Accelerated Approval Re-Reviews: US FDA’s Pazdur Is Not Backing Down
How has FDA suddenly been able to enforce accelerated approval commitments in oncology? The agency’s Richard Pazdur reflects on lessons from 2021 – and promises more re-reviews to come.
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Accelerated Approval: Acrotech’s Confirmatory Trial For Folotyn, Beleodaq More Than A Decade Behind Schedule
Under sponsor's current timetable, a single, two-part trial for pralatrexate and belinostat would not complete until 2030, resulting in respective delays of 21 and 16 years in confirming or refuting clinical benefit following accelerated approval. ODAC will discuss Acrotech’s delayed confirmatory trial program on 16 November.
Indicating that failure should be expected may be a subtle reminder of the potential consequences of placing more guardrails on the expedited approval pathway.
Unger Unplugged: FDA Needs Accelerated Approval To ‘Take More Chances’ – But Also A Clear Path To Withdrawal
Former cardiology review office director Ellis Unger suggests 70% chance for AA drugs to confirm benefit is an appropriate benchmark, but agency comes nowhere close to withdrawing the remaining 30%.