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. 2022 Jul 28;56(5):698–703. doi: 10.1007/s43441-022-00430-z

Table 1.

Accelerated approvals by decade cohort: converted, withdrawn, pending completion [5]

1992–2001 summary data 2002—2011 summary data 2012—2021 summary data
Total accelerated approvals granted 52 Total accelerated approvals granted 59 Total accelerated approvals granted 167
Converted 44 Converted 44 Converted 51
Confirmatory trials pending 2 Confirmatory trials pending 3 Confirmatory trials pending 102
Of 44 converted, average time to confirm clinical benefit was 4.5 years, with a median of 3.9 years Of 44 converted, average time to confirm clinical benefit was 5 years, with a median of 4.1 years Of 51 converted, average time to confirm clinical benefit was 2.5 years, with a median of 2.3 years
Of 6 withdrawn, the average time to withdrawal was 8.9 years, with a median of 10.4 years Of 12 withdrawn, the average time to withdrawal was 9.9 years, with a median of 9.7 years Of 14 withdrawn, the average time to withdrawal was 3.7 years, with a median of 3.5 years