Many cancer drugs remain unproven 5 years after accelerated approval, study finds
Many cancer drugs remain unproven 5 years after accelerated approval, study finds
The FDA's accelerated approval program, meant to speed access to promising drugs, grants approval based on promising initial results.
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“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 allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases.
In exchange, drug companies are expected to do rigorous testing and produce better evidence before gaining full approval.
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.
The FDA can now require that a confirmatory trial be underway when it grants preliminary approval, which speeds up the process of verifying whether a drug works, she said.
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