An accelerated drug approval that continues even though a confirmatory trial has not validated that the drug has clinical benefit
Deeper dive
Officials at the FDA’s Oncology Center of Excellence coined the term “dangling” approval in a paper published in 2021 in the New England Journal of Medicine. The agency states that as a condition of accelerated approval, a drugmaker should conduct confirmatory trials to verify that a drug helps patients under the clinical indication for which it was approved, with a positive result prompting conversion to traditional approval. The paper pointed to several drugs that maintained marketing approval despite not showing a benefit in a confirmatory trial. Historically the FDA has had difficulty rescinding accelerated approvals but the Food and Drug Omnibus Reform Act of 2022 streamlined the process. Still, the agency has latitude in enforcement. It states on its website that it continually reviews accelerated approvals to ensure safety and effectiveness but in cases where there are unmet medical needs and “reasons for a confirmatory trial not verifying clinical benefit,” a drug may remain on the market while another confirmatory trial is completed.