Table 1 Characteristics of applications.
From: Association between control group therapy and magnitude of clinical benefit of cancer drugs
Characteristics | N (%) | |
|---|---|---|
164 (100) | ||
Submission type | Initial | 44 (27) |
Supplemental | 120 (73) | |
Type of approval | Regular | 154 (94) |
Accelerated | 10 (6) | |
Breakthrough therapy designation | Yes | 46/153 (30) |
No | 107/153 (70) | |
Priority review | Yes | 127/158 (80) |
No | 31/158 (20) | |
Orphan drug designation | Yes | 74/162 (46) |
No | 88/162 (54) | |
Companion diagnostic | Yes | 51 (31) |
No | 113 (69) | |
Number of trials supporting approval | One | 158 (96) |
More than one | 6 (4) | |
Approval based on subgroup analysis | Yes | 33 (20) |
No | 131 (80) | |
Drug class | Chemotherapy and hormone therapy | 17 (10) |
Immunotherapy and targeted therapy | 145 (89) | |
Other | 2 (1) | |
Primary cancer site | Lung, breast, colorectal, prostate | 81 (49) |
Other | 83 (51) | |
