Table 1.
Summary of new oncology therapy approvals with RWE for efficacy from 2015 to 2020a.
| Oncology drugs approved from 2015 to 2020 | |||
|---|---|---|---|
| (N = 11) | |||
| NDA or BLA, N (%) | |||
| NDA | 7 | (63.6) | |
| BLA | 4 | (36.4) | |
| Time between IND submission and approval (years), mean [median] (min, max) | 5.7 | [5.5] | (2.8, 8.4) |
| Year of approvalb, N (%) | |||
| 2015–2016 | 0 | (0.0) | |
| 2017 | 2 | (18.2) | |
| 2018 | 0 | (0.0) | |
| 2019 | 4 | (36.4) | |
| 2020 | 5 | (45.5) | |
| New molecular entity, N (%) | |||
| Yes | 10 | (90.0) | |
| No | 1 | (9.1) | |
| Orphan drug, N (%) | |||
| Yes | 10 | (90.0) | |
| No | 1 | (9.1) | |
| Fast track, N (%) | |||
| Yes | 6 | (54.5) | |
| No | 5 | (45.5) | |
| Breakthrough therapy, N (%) | |||
| Yes | 8 | (72.7) | |
| No | 3 | (27.3) | |
| Priority review, N (%) | |||
| Yes | 11 | (100.0) | |
| No | 0 | (0.0) | |
| Accelerated approval, N (%) | |||
| Yes | 8 | (72.7) | |
| NA (full approval) | 3 | (27.3) | |
Abbreviation: NA: Not Applicable.
aFindings are based on publicly available information posted on the FDA website as of January 15, 2021.
bThere were no approvals involving RWE for efficacy in 2015–2016.