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Many cancer drugs remain unproven 5 years after accelerated approval, a study finds
Researchers have found that most cancer drugs granted accelerated approval by the U.S. Food and Drug Administration do not deliver on their early promise.
“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. Congress recently updated the program, giving the FDA more authority and streamlining the process for withdrawing drugs when companies don’t meet their commitments.
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