Excuses, Excuses: How ‘Delayed’ Confirmatory Trials Are Explained By FDA
US FDA currently reports about two dozen Accelerated Approval having ‘delays’ in the confirmatory trials. COVID is one factor in some – and the agency also appears to be clearing out some of the others.
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The latest accelerated approval withdrawals in the US are milestones for accountability in the program – most notably with the withdrawal of an antimicrobial with confirmatory studies more than a decade overdue.
Of products that have had accelerated approval for at least a decade, just 6% are still marketed without the promised confirmatory evidence. And those include cases like ‘antibiotics approved for inhalational anthrax, where the lack of confirmatory clinical trial is a good thing.’ FDA’s Corrigan-Curay says.
Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due to confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.