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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