Characteristics of oncology therapeutics approved by the US Food and Drug Administration, 2012-17
| Characteristic | Number (%) |
| Product type: | |
| Drug | 39/59 (66) |
| Biologic | 20/59 (34) |
| Sponsors | 25 |
| Approval year: | |
| 2012 | 11/59 (19) |
| 2013 | 8/59 (14) |
| 2014 | 8/59 (14) |
| 2015 | 14/59 (24) |
| 2016 | 4/59 (7) |
| 2017 | 14/59 (24) |
| Approval pathway: | |
| Priority review | 46/59 (78) |
| Accelerated approval | 28/59 (47) |
| Fast track | 30/59 (51) |
| Breakthrough | 27/59 (46) |
| Orphan drug status | 45/59 (76) |
| Broad oncological indication: | 16 |
| Leukemia | 10/59 (17) |
| Lung cancer | 6/59 (10) |
| Breast cancer | 6/59 (10) |
| Multiple myeloma | 6/59 (10) |
| Non-Hodgkin’s lymphoma | 6/59 (10) |
| Melanoma | 5/59 (8) |
| Colorectal cancer | 3/59 (5) |
| Ovarian cancer | 3/59 (5) |
| Other* | 13/59 (22) |
| Pivotal trials: | 64 |
| Median, per product | 1 |
| Mean, per product | 1.08 |
| Trial participants: | 29 959 |
| Median, per trial | 326 (138-668) |
Data are n/N, number (%), or median (interquartile), unless otherwise specified.
*Other includes basal cell carcinoma (n=2), prostate cancer (n=2), soft tissue sarcoma (n=2), thyroid cancer (n=2), urothelial carcinoma (n=2), gastric cancer (n=1), renal cell carcinoma (n=1), and merkel cell carcinoma (n=1).