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Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims

 
• By Bridget Silverman

US FDA’s accelerated approvals hit a contemporary high in 2021, accounting for one-third of novel US approvals, but the big story was the agency’s crackdown on delinquent confirmatory trials for oncology AA indications.

Big splash
• Source: Alamy

The US FDA’s accelerated approval program has proven a reliable magnet for news coverage, but even so 2021 stands out as particularly dramatic. The agency’s Oncology Center of Excellence undertook a significant review of “dangling” accelerated approvals that resulted in the removal of 13 indications, while at the same time approving 14 novel agents via accelerated approval – a high water mark for the review pathway.

And of course, one of those novel accelerated approvals was Biogen, Inc./Eisai Co., Ltd.’s Aduhelm (aducanumab-avwa), one of the FDA’s most controversial approval decisions ever. (Also see "

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• By Sarah Karlin-Smith

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