"Study Reveals Lack of Evidence for Many Accelerated Approval Cancer Drugs"

A study found that most cancer drugs granted accelerated approval by the FDA do not demonstrate clinical benefits within five years, despite the program being intended to give patients early access to promising drugs. Between 2013 and 2017, 63% of cancer drugs granted accelerated approval were converted to regular approval, even though only 43% demonstrated a clinical benefit in confirmatory trials. The study raises concerns about whether patients understand the uncertainty surrounding drugs with accelerated approval and emphasizes the importance of doctors carefully explaining the evidence to patients. Congress recently updated the program, giving the FDA more authority and streamlining the process for withdrawing drugs when companies don’t meet their commitments.