Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval
Ian T. T. Liu,
Aaron S. Kesselheim,
Edward R. Scheffer Cliff
Abstract:ImportanceThe US Food and Drug Administration’s (FDA) accelerated approval pathway allows approval of investigational drugs treating unmet medical needs based on changes to surrogate measures considered “reasonably likely” to predict clinical benefit. Postapproval clinical trials are then required to confirm whether these drugs offer clinical benefit.ObjectiveTo determine whether cancer drugs granted accelerated approval ultimately demonstrate clinical benefit and to evaluate the basis of conversion to regular… Show more
“…Most cancer drugs granted accelerated approval in the US did not demonstrate benefit in overall survival or quality of life in confirmatory trials after more than five years of follow-up, a new study shows 1…”
“…Most cancer drugs granted accelerated approval in the US did not demonstrate benefit in overall survival or quality of life in confirmatory trials after more than five years of follow-up, a new study shows 1…”
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