Many cancer drugs remain unproven 5 years after accelerated approval, a study finds
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A study has found that most cancer drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) do not demonstrate clinical benefits within five years. Between 2013 and 2017, 46 cancer drugs were granted accelerated approval, but only 43% demonstrated a clinical benefit in confirmatory trials. The accelerated approval program was created in 1992 to speed access to HIV drugs and now 85% of accelerated approvals go to cancer drugs. The program allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases. However, drug companies are expected to do rigorous testing and produce better evidence before gaining full approval. The study raises concerns about whether cancer patients understand the uncertainty surrounding drugs with accelerated approval. Congress recently updated the program, giving the FDA more authority and streamlining the process for withdrawing drugs when companies don't meet their commitments.

#CancerDrugs #Fda #AcceleratedApproval #ClinicalBenefits #ConfirmatoryTrials #HivDrugs #DrugCompanies #Congress

https://apnews.com/article/cancer-drugs-fda-accelerated-approval-d5adffd124e0d038a8fd0357ced59546