Impact of Availability of Companion Diagnostics on the Clinical Development of Anticancer Drugs

Background Companion diagnostics permit the selection of patients likely to respond to targeted anticancer drugs; however, it is unclear if the drug development process differs between drugs developed with or without companion diagnostics. Identification of differences in study design could help fut...

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Bibliographic Details
Published in:Molecular diagnosis & therapy 2017-06, Vol.21 (3), p.337-343
Main Authors: Tibau, Ariadna, Díez-González, Laura, Navarro, Beatriz, Galán-Moya, Eva M., Templeton, Arnoud J., Seruga, Bostjan, Pandiella, Atanasio, Amir, Eitan, Ocana, Alberto
Format: Article
Language:English
Subjects:
Antineoplastic drugs
Antitumor agents
Biomedical and Life Sciences
Biomedicine
Cancer Research
Cancer therapies
Clinical trials
Design
Diagnostic systems
Diagnostic tests
Drug development
Drug dosages
Drugs
Genomes
Human Genetics
Identification
Laboratory Medicine
Lung cancer
Metastasis
Molecular Medicine
Original Research Article
Patients
Pharmaceutical industry
Pharmacotherapy
Registration
Regulatory approval
Solid tumors
Studies
Tumors
Websites
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Summary:Background Companion diagnostics permit the selection of patients likely to respond to targeted anticancer drugs; however, it is unclear if the drug development process differs between drugs developed with or without companion diagnostics. Identification of differences in study design could help future clinical development. Patients and Methods Anticancer drugs approved for use in solid tumors between 28 September 2000 and 4 January 2014 were identified using a search of the US FDA website. Phase III trials supporting registration were extracted from the drug label. Each published study was reviewed to obtain information about the phase I and II trials used for the development of the respective drug. Results We identified 35 drugs and 59 phase III randomized trials supporting regulatory approval. Fifty-three phase I trials and 47 phase II trials were cited in the studies and were used to support the design of these phase III trials. The approval of drugs using a companion diagnostic has increased over time ( p for trend 0.01). Expansion cohorts were more frequently observed with drugs developed with a companion diagnostic (62 vs. 20%; p  = 0.005). No differences between drugs developed with or without a companion diagnostic were observed for the design of phase I and II studies. Conclusions The approval of drugs developed with a companion diagnostic has increased over time. The availability of a companion diagnostic was associated with more frequent use of phase I expansion cohorts comprising patients selected by the companion diagnostic.
ISSN:1177-1062
1179-2000
DOI:10.1007/s40291-017-0267-y