The FDA's accelerated approval program is meant to give patients early access to promising drugs, but a new study found most cancer drugs do not demonstrate benefits within five years.
The U.S. Food and Drug Administration's accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients' lives?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.
Of those, 63% were converted to regular approval even though only 43% demonstrated a clinical benefit in confirmatory trials.The research was published in the Journal of the American Medical Association and discussed at the American Association for Cancer Research annual meeting in San Diego on Sunday.It's unclear how much cancer patients understand about drugs with accelerated approval, said study co-author Dr. Edward Cliff of Harvard Medical School.
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