Many cancer drugs remain unproven 5 years after accelerated approval, a study finds
8 months, 2 weeks ago

Many cancer drugs remain unproven 5 years after accelerated approval, a study finds

Associated Press  

The U.S. Food and Drug Administration’s accelerated approval program is meant to give patients early access to promising drugs. In a new study, researchers found that most cancer drugs granted accelerated approval do not demonstrate such benefits within five years. “Five years after the initial accelerated approval, you should have a definitive answer,” said Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania who was not involved in the research. It’s unclear how much cancer patients understand about drugs with accelerated approval, said study co-author Dr. Edward Cliff of Harvard Medical School. Drugs that got accelerated approval may be the only option for patients with rare or advanced cancers, said Dr. Jennifer Litton of MD Anderson Cancer Center in Houston, who was not involved in the study.

History of this topic

Many cancer drugs remain unproven 5 years after accelerated approval, a study finds
8 months, 2 weeks ago
Speedier drug approvals hit slowdown as FDA faces scrutiny
2 years ago
5 things to know about the FDA's flawed approach to accelerated drug approvals
2 years, 4 months ago
FDA to scrutinize unproven cancer drugs after 10-year gap
3 years, 7 months ago

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