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Table 1 Characteristics and gene targets for oncology medicines approved by FDA

From: Delivering the precision oncology paradigm: reduced R&D costs and greater return on investment through a companion diagnostic informed precision oncology medicines approach

 

CDx (N = 42)

Non-CDx (N = 29)

CDxsa

  

ALK

3 (7.1)

–

BCR-ABL+

1 (2.4)

–

BCR-ABL−

1 (2.4)

–

BRAF

4 (11.9)

–

BRCA

2 (4.8)

–

EGFR

3 (7.1)

–

EZH2

1 (2.4)

–

FGFR

1 (2.4)

–

FLT3+

2 (4.8)

–

HER2+

8 (19.0)

–

HER2−

3 (7.1)

–

IDH1

1 (2.4)

–

IDH2

1 (2.4)

–

MET

1 (2.4)

–

NTRK

2 (4.8)

–

PDGFRA

1 (2.4)

–

PD-L1

3 (7.1)

–

PIK3CA

1 (2.4)

–

RAS

1 (2.4)

–

RET

2 (4.8)

–

ROS

1 (2.4)

–

No CDx

–

29 (100.0)

Small molecule

31 (73.8)

12 (41.4)

Biologic

11 (26.2)

17 (58.6)

Orphan drug

28 (66.7)

20 (69.0)

First in class

15 (35.7)

15 (51.7)

Expedited program

40 (95.2)

24 (82.8)

Approval dates

  

 1997–2002

1 (2.4)

2 (6.9)

 2003–2008

4 (9.5)

2 (6.9)

 2009–2014

7 (16.7)

9 (31.0)

 2015–2020

30 (71.4)

16 (55.2)

  1. ALK anaplastic lymphoma kinase, BCR-ABL1 breakpoint cluster region and Abelson murine leukemia, BRAF− proto-oncogene B-Raf, BRCA breast cancer; precision companion diagnostic, EGFR− epidermal growth factor receptor, EZH2 enhancer of zeste homolog 2; FGFR fibroblast growth factor receptor, FLT3 fms like tyrosine kinase 3, HER2 human epidermal growth factor receptor 2, IDH isocitrate dehydrogenase, MET MET gene, n number; NTRK neurotrophin receptor tyrosine kinase, PDGFRA platelet-derived growth factor receptor A, PD-L1 programmed death ligand 1, PIK3CA phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha, RAS rat sarcoma virus oncogene, RET rearranged during transfection, ROS c-ros oncogene
  2. aProportions amongst CDxs may not round to 100% as some drugs have multiple CDxs