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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...

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More from United States

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user free appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.

Medicare Part D LIS Access Threatened By House Budget Bill’s Medicaid Obstacles

 
• By Cathy Kelly

An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.

More from North America

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

Anti-Vaccine Activists Among New US CDC Vaccine Advisors

 
• By Sarah Karlin-Smith

HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.

US FDA May Consolidate Support Services After Extensive Cuts

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.