Table 1. Drugs Granted FDA Accelerated Approval for Original Indications and Converted to Standard Approval, 2012 to 2017.
| Drugs, No. (%) | P value | |||
|---|---|---|---|---|
| Total | Converteda | Not converted | ||
| All drugs | 38 | 22 (58) | 16 (42) | NA |
| Approval year | .41 | |||
| 2012 | 6 | 4 (67) | 2 (33) | |
| 2013 | 2 | 2 (100) | 0 (0) | |
| 2014 | 8 | 5 (63) | 3 (38) | |
| 2015 | 8 | 6 (75) | 2 (25) | |
| 2016 | 7 | 2 (29) | 5 (71) | |
| 2017 | 7 | 3 (43) | 4 (57) | |
| Drug type | .71 | |||
| Small molecule | 29 | 16 (55) | 13 (45) | |
| Biologic | 9 | 6 (67) | 3 (33) | |
| Therapeutic area | .06 | |||
| Cancer | 28 | 19 (68) | 9 (32) | |
| Noncancer | 10 | 3 (30) | 7 (70) | |
| Orphan drug designation | .56 | |||
| Yes | 35 | 21 (60) | 14 (40) | |
| No | 3 | 1 (33) | 2 (67) | |
| Confirmatory trial primary outcome | .49 | |||
| Clinical outcome | 13 | 6 (46) | 7 (54) | |
| Surrogate end point | 23 | 15 (65) | 8 (35) | |
| No datab | 2 | 1 (50) | 1 (50) | |
| Supplemental indication | <.001 | |||
| Yes | 20 | 17 (85) | 3 (15) | |
| No | 18 | 5 (28) | 13 (72) | |
Abbreviations: FDA, US Food and Drug Administration; NA, not applicable.
a
Conversion status as of December 31, 2020.
b
For 1 converted and 1 unconverted drug, postapproval clinical trial registrations meeting FDA requirements could not be identified.