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

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