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Table 1 Characteristics of oncology drug approvals

From: Response rate of anticancer drugs approved by the Food and Drug Administration based on a single-arm trial

   SAT n (%)
n = 35
RCT n (%)
n = 66
Approval Year 2016 4 (11.4) 9 (13.6)
2017 12 (34.3) 16 (24.2)
2018 11 (31.4) 22 (33.3)
2019 8 (22.9) 19 (28.8)
Cancer Type Bladder 7 (20.0) 1 (1.5)
Breast 2 (5.7) 14 (21.2)
Colorectal 2 (5.7) 0
Gastric 1 (2.9) 1 (1.5)
Head and Neck 1 (2.9) 2 (3.0)
Kidney 0 7 (10.6)
Liver 2 (5.7) 4 (6.1)
Lung 8 (22.9) 15 (22.7)
Neuroendocrine tumors 0 2 (3.0)
Ovarian 2 (5.7) 5 (7.6)
Prostate 0 6 (9.1)
Skin 3 (8.6) 4 (6.1)
Tumor agnostic 3 (8.6) 0
Other 4 (11.4) 5 (7.6)
Mechanism of Action Antibody drug conjugate 2 (5.7) 1 (1.5)
Androgen receptor inhibitor 0 6 (9.1)
Immune checkpoint inhibitor 18 (51.4) 19 (28.8)
Molecularly-targeted drug 11 (31.4) 34 (51.5)
Combo 3 (8.6) 3 (4.5)
Other 1 (2.9) 3 (4.5)
Review Process Breakthrough therapy 22 (62.9) 21 (31.8)
Accelerated approval 26 (74.3) 3 (4.5)
Fast track 2 (5.7) 5 (7.6)
Priority review 34 (97.1) 46 (69.7)
Orphan 10 (28.6) 14 (21.2)
  1. RCT randomized clinical trial, SAT single-arm trial