Most cancer drugs granted accelerated approval do not demonstrate such benefits within five years. The new study found that between 2013 and 2017, 63% of cancer drugs converted to regular approval without demonstrating a clinical benefit in confirmatory trials.
The FDA's accelerated approval program aims to speed access to promising drugs for fatal diseases like cancer. Drug companies are expected to conduct rigorous testing for full approval after the initial accelerated approval.
It's up to the FDA or the drugmaker to withdraw disappointing drugs, with some drugs gaining full approval despite less definitive evidence. The study raises concerns about patient understanding of drugs with accelerated approval.
It's unclear how much cancer patients understand about drugs with accelerated approval. We raise the question.
#accelerated-approval-program #cancer-drugs #fda-regulations #clinical-trials #patient-understanding
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