Since December 2020, 20 indications that received US Food and Drug Administration accelerated approval have been voluntarily withdrawn by sponsors. Almost all were cancer drugs ensnared in the Oncology Center of Excellence’s push to clean up “dangling” and “delinquent” indications for which confirmatory trials have failed to verify clinical benefit or were never completed.
Two Years In US Accelerated Approval Withdrawals
Twenty accelerated approval indications have been voluntarily withdrawn by sponsors since December 2020, most coming as a result of the FDA cancer office’s push to rid labeling of ‘dangling’ and ‘delinquent’ indications that lack confirmation of clinical benefit.
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