Table 1.
Characteristics of novel oncology drugs approved by the FDA (2012–2022).
| All drugs | Drugs with a dosing PMR | |||||||
|---|---|---|---|---|---|---|---|---|
| All years | 2012–2015 | 2016–2019 | 2020–2022 | All years | 2012–2015 | 2016–2019 | 2020–2022 | |
| Total | 132 | 42 (31.8) | 44 (33.3) | 46 (34.8) | 78 (59.1) | 26 (61.9) | 23 (52.3) | 29 (63) |
| Application type | ||||||||
| NDA | 82 (62.1) | 29 (35.4) | 29 (35.4) | 24 (29.3) | 66 (80.5) | 25 (86.2) | 22 (75.9) | 19 (79.2) |
| BLA | 50 (37.9) | 13 (26) | 15 (30) | 22 (44) | 12 (24) | 1 (7.7) | 1 (6.7) | 10 (45.5) |
| Approval type | ||||||||
| Accelerated approval | 71 (53.8) | 25 (35.2) | 26 (36.6) | 20 (28.2) | 35 (49.3) | 13 (52) | 12 (46.2) | 10 (50) |
| Regular approval | 61 (46.2) | 17 (27.9) | 18 (29.5) | 26 (42.6) | 43 (70.5) | 13 (76.5) | 11 (61.1) | 19 (73.1) |
| Drug class | ||||||||
| Molecular target inhibitors | 68 (51.5) | 23 (33.8) | 27 (39.7) | 18 (26.5) | 56 (82.4) | 20 (87) | 21 (77.8) | 15 (83.3) |
| Monoclonal antibody/ADCs | 38 (28.8) | 11 (28.9) | 11 (28.9) | 16 (42.1) | 11 (28.9) | 1 (9.1) | 1 (9.1) | 9 (56.3) |
| Chemotherapiesa | 8 (6.1) | 5 (62.5) | — | 3 (37.5) | 7 (87.5) | 4 (80) | — | 3 (100) |
| Cell and gene therapies | 8 (6.1) | 1 (12.5) | 2 (25) | 5 (62.5) | — | — | — | — |
| Endocrine therapies/hormone antagonists and related agents | 4 (3.0) | 1 (25) | 2 (50) | 1 (25) | — | — | — | — |
| Radiopharmaceuticals | 3 (2.3) | 1 (33.3) | 1 (33.3) | 1 (33.3) | 3 (100) | 1 (100) | 1 (100) | 1 (100) |
| Otherb | 3 (2.3) | — | 1 (33.3) | 2 (66.7) | 1 (33.3) | — | — | 1 (50) |
| Disease setting | ||||||||
| Advanced | 124 (93.9) | 41 (33.1) | 39 (31.5) | 44 (35.5) | 75 (60.5) | 26 (63.4) | 21 (53.8) | 28 (63.6) |
| Both | 4 (3) | 1 (25) | 2 (50) | 1 (25) | 1 (25) | — | — | 1 (100) |
| Early stage | 4 (3) | — | 3 (75) | 1 (25) | 2 (50) | — | 2 (66.7) | — |
aChemotherapies include three alkylating agents, two antimetabolites, one protein biosynthesis inhibitor, and two angiogenesis inhibitors.
b Other includes two antineoplastic enzymes and one hypoxia-inducible factor (HIF) inhibitor. BLA, biologics license application; NDA, new drug application; ADC, antibody-drug conjugate.