Retrospective cohort study of predictors of withdrawal of anticancer drug indications granted accelerated approval

The accelerated approval pathway allows the FDA to approve drugs for serious conditions based on promising surrogate measures., with confirmatory studies required later. A retrospective study of anticancer drug indications accelerated approval bij the FDA found that indications based on early data suggesting limited clinical benefit tend to have higher withdrawal rates, whereas therapies with Breakthrough Therapy designation and genome-targeted mechanisms are more likely to validate clinical benefits and achieve regular approval.