Trends in Time to Withdrawal and Full Approval of Accelerated Approval Cancer Drug Indications (1992-2024)

The median time from FDA accelerated approval to full approval for cancer drugs decreased from 4.3 years in 1992 to 2.3 years in 2025, with a reduction in median withdrawal time from 9.5 to 3.2 years. The proportion of confirmatory studies underway at approval rose from 63% to 85% during this period. These findings may reflect improved regulatory oversight or more flexible approval, highlighting the need for timely, clinically meaningful confirmatory evidence to ensure real patient benefit and reduce uncertainty.