Trends in time to withdrawal and full approval of accelerated approval cancer drug indications (1992–2024)

Abstract

The US Food and Drug Administration (FDA) accelerated approval program facilitates earlier access to therapies for serious illnesses based on surrogate endpoints reasonably likely to predict clinical benefit. To minimize risk, sponsors are required to conduct post marketing studies to confirm the benefit. Over the past decade, concerns have emerged about the pace and quality of post marketing evidence generation. We analyzed regulatory outcomes of oncology indications granted accelerated approval between 1992 and 2024, using publicly available FDA data. Median time to conversion to regular approval decreased from 4.3 to 2.3 years and time to withdrawal decreased from 9.5 to 3.2 years between the 1992–2013 and 2014–2024 periods (both p < 0.001). The proportion of indications with confirmatory studies underway at the time of accelerated approval increased from 63 % to 85 % (p = 0.003). Findings remained consistent across sensitivity analyses. Although these trends may reflect stronger oversight, advances in clinical trial design and regulatory coordination may also contribute. Faster regulatory timelines must be accompanied by timely generation of post-approval clinical evidence to maintain the integrity of the accelerated approval pathway.