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Withdrawn | 10 (22) | 6 (25) | 4 (18) |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) |