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Defending accelerated approval. Plus: endpoint innovation & AIM amiss: a BioCentury podcast

Why it’s wrong to conclude half of cancer accelerated approvals are useless

By Jeff Cranmer, Executive Editor

April 22, 2024 11:55 PM UTC

A “drive-by analysis of accelerated approval is intellectual malpractice,” argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues explain why a paper on the expedited regulatory pathway written by researchers at the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital misleads the public about the value of drugs granted accelerated approval. The paper also fails to grasp the pathway’s purpose, which is “to allow risk-taking when there’s evidence that a therapy is reasonably likely to benefit patients who are suffering from a serious condition,” Usdin writes in the Editor’s Commentary.

BioCentury’s editors also discuss how an FDA advisory committee’s support for a myeloma metric makes the broader case for endpoint innovation; why a group of biotechs is delisting from U.K. stock exchange AIM; and the launch of well-funded obesity play  Metsera Inc.

For more of BioCentury’s coverage of obesity therapeutics, see our Hot Topics page. For information on opportunities to sponsor The BioCentury Show and the BioCentury This Week podcast, please email conferences@biocentury.com.