"Study: Accelerated Approval Fails for Many Cancer Drugs"
Originally Published 1 year ago — by NBC News
A study found that most cancer drugs granted accelerated approval by the FDA do not demonstrate clinical benefits within five years, raising concerns about patient access to unproven medications. Despite the program's intention to speed access to promising drugs, only 43% of the drugs demonstrated a clinical benefit in confirmatory trials, yet 63% were converted to regular approval. The study highlights the need for better communication of uncertainty to patients and the importance of careful explanation by doctors. Recent updates to the program give the FDA more authority to withdraw drugs when companies don't meet their commitments, aiming to streamline the process for verifying drug efficacy.