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. 2024 Apr 7;331(17):1471–1479. doi: 10.1001/jama.2024.2396

Table. Pivotal Trials Supporting Accelerated Approvals and Regulatory Outcomes of Oncology Accelerated Approval Drug-Indication Pairs, 2013 to 2017.

No. (%)
All indications (n = 46) Original indications (n = 24) Supplemental indications (n = 22)
Pivotal trial efficacy outcomes
Response rate 19 (41) 9 (38) 10 (45)
Response rate plus duration of response 21 (46) 11 (46) 10 (45)
Progression-free survival 4 (9) 2 (8) 2 (9)
Overall survival 1 (2) 1 (4) 0
Complete remission rate 1 (2) 1 (4) 0
Regulatory outcome
Converted to regular approval 29 (63) 14 (58) 15 (68)
Ongoing 7 (15) 4 (17) 3 (14)
Withdrawn 10 (22) 6 (25) 4 (18)
Time to conversion, median (IQR), d 972 (680-1274)
Time to withdrawal, median (IQR), d 1923 (1449-2517)