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Two Years In US Accelerated Approval Withdrawals

 
• By Sue Sutter

Twenty accelerated approval indications have been voluntarily withdrawn by sponsors since December 2020, most coming as a result of the FDA cancer office’s push to rid labeling of ‘dangling’ and ‘delinquent’ indications that lack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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The Oncology Center of Excellence has aggressively moved to clean up ‘dangling’ accelerated approval indications in the past two years. • Source: Shutterstock

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December 2020, 20 indications that received US Food and Drug Administration accelerated approval have been voluntarily withdrawn by sponsors.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.

Below is a timeline of the withdrawal announcements, along with relevant related events, such as meetings of the Oncologic Drugs Advisory Committee. Unless otherwise noted, the date listed reflects the...

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