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Companion Diagnostics for Targeted Cancer Drugs – Clinical and Regulatory Aspects

Companion diagnostics (CDx) holds the promise of improving the predictability of the oncology drug development process and become an important tool for the oncologist in relation to the choice of treatment for the individual patient. A number of drug–diagnostic co-development programs have already b...

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Detalles Bibliográficos
Autores principales: Olsen, Dana, Jørgensen, Jan Trøst
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4032883/
https://www.ncbi.nlm.nih.gov/pubmed/24904822
http://dx.doi.org/10.3389/fonc.2014.00105
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author Olsen, Dana
Jørgensen, Jan Trøst
author_facet Olsen, Dana
Jørgensen, Jan Trøst
author_sort Olsen, Dana
collection PubMed
description Companion diagnostics (CDx) holds the promise of improving the predictability of the oncology drug development process and become an important tool for the oncologist in relation to the choice of treatment for the individual patient. A number of drug–diagnostic co-development programs have already been completed successfully, and in the clinic, the use of several targeted cancer drugs is now guided by a CDx. This central role of the CDx assays has attracted the attention of the regulators, and especially the US Food and Drug Administration has been at the forefront in relation to developing regulatory strategies for CDx and the drug–diagnostic co-development project. For an increasing number of cancer patients the treatment selection will depend on the result generated by a CDx assay, and consequently this type of assay has become critical for the care and safety of the patients. In order to secure that the CDx assays have a high degree of analytical and clinical validity, they must undergo an extensive non-clinical and clinical testing before release for routine patient management. This review will give a brief introduction to some of the scientific and medical challenges related to the CDx development with specific emphasis on the regulatory requirements in different regions of the world.
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spelling pubmed-40328832014-06-05 Companion Diagnostics for Targeted Cancer Drugs – Clinical and Regulatory Aspects Olsen, Dana Jørgensen, Jan Trøst Front Oncol Oncology Companion diagnostics (CDx) holds the promise of improving the predictability of the oncology drug development process and become an important tool for the oncologist in relation to the choice of treatment for the individual patient. A number of drug–diagnostic co-development programs have already been completed successfully, and in the clinic, the use of several targeted cancer drugs is now guided by a CDx. This central role of the CDx assays has attracted the attention of the regulators, and especially the US Food and Drug Administration has been at the forefront in relation to developing regulatory strategies for CDx and the drug–diagnostic co-development project. For an increasing number of cancer patients the treatment selection will depend on the result generated by a CDx assay, and consequently this type of assay has become critical for the care and safety of the patients. In order to secure that the CDx assays have a high degree of analytical and clinical validity, they must undergo an extensive non-clinical and clinical testing before release for routine patient management. This review will give a brief introduction to some of the scientific and medical challenges related to the CDx development with specific emphasis on the regulatory requirements in different regions of the world. Frontiers Media S.A. 2014-05-16 /pmc/articles/PMC4032883/ /pubmed/24904822 http://dx.doi.org/10.3389/fonc.2014.00105 Text en Copyright © 2014 Olsen and Jørgensen. http://creativecommons.org/licenses/by/3.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Oncology
Olsen, Dana
Jørgensen, Jan Trøst
Companion Diagnostics for Targeted Cancer Drugs – Clinical and Regulatory Aspects
title Companion Diagnostics for Targeted Cancer Drugs – Clinical and Regulatory Aspects
title_full Companion Diagnostics for Targeted Cancer Drugs – Clinical and Regulatory Aspects
title_fullStr Companion Diagnostics for Targeted Cancer Drugs – Clinical and Regulatory Aspects
title_full_unstemmed Companion Diagnostics for Targeted Cancer Drugs – Clinical and Regulatory Aspects
title_short Companion Diagnostics for Targeted Cancer Drugs – Clinical and Regulatory Aspects
title_sort companion diagnostics for targeted cancer drugs – clinical and regulatory aspects
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4032883/
https://www.ncbi.nlm.nih.gov/pubmed/24904822
http://dx.doi.org/10.3389/fonc.2014.00105
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