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Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020)
Pharmacogenomics (PGx) is a key subset of precision medicine that relates genomic variation to individual response to pharmacotherapy. We assessed longitudinal trends in US FDA approval of new drugs labeled with PGx information. Drug labels containing PGx information were obtained from Drugs@FDA and...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8000585/ https://www.ncbi.nlm.nih.gov/pubmed/33806453 http://dx.doi.org/10.3390/jpm11030179 |
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author | Kim, Jeeyun A. Ceccarelli, Rachel Lu, Christine Y. |
author_facet | Kim, Jeeyun A. Ceccarelli, Rachel Lu, Christine Y. |
author_sort | Kim, Jeeyun A. |
collection | PubMed |
description | Pharmacogenomics (PGx) is a key subset of precision medicine that relates genomic variation to individual response to pharmacotherapy. We assessed longitudinal trends in US FDA approval of new drugs labeled with PGx information. Drug labels containing PGx information were obtained from Drugs@FDA and guidelines from PharmGKB were used to compare the actionability of PGx information in drug labels across therapeutic areas. The annual proportion of new drug approvals with PGx labeling has increased by nearly threefold from 10.3% (n = 3) in 2000 to 28.2% (n = 11) in 2020. Inclusion of PGx information in drug labels has increased for all clinical areas over the last two decades but most prominently for cancer therapies, which comprise the largest proportion (75.5%) of biomarker–drug pairs for which PGx testing is required. Clinically actionable information was more frequently observed in biomarker–drug pairs associated with cancer drugs compared to those for other therapeutic areas (n = 92 (59.7%) vs. n = 62 (40.3%), p < 0.0051). These results suggest that further evidence is needed to support the clinical adoption of pharmacogenomics in non-cancer therapeutic areas. |
format | Online Article Text |
id | pubmed-8000585 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-80005852021-03-28 Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020) Kim, Jeeyun A. Ceccarelli, Rachel Lu, Christine Y. J Pers Med Article Pharmacogenomics (PGx) is a key subset of precision medicine that relates genomic variation to individual response to pharmacotherapy. We assessed longitudinal trends in US FDA approval of new drugs labeled with PGx information. Drug labels containing PGx information were obtained from Drugs@FDA and guidelines from PharmGKB were used to compare the actionability of PGx information in drug labels across therapeutic areas. The annual proportion of new drug approvals with PGx labeling has increased by nearly threefold from 10.3% (n = 3) in 2000 to 28.2% (n = 11) in 2020. Inclusion of PGx information in drug labels has increased for all clinical areas over the last two decades but most prominently for cancer therapies, which comprise the largest proportion (75.5%) of biomarker–drug pairs for which PGx testing is required. Clinically actionable information was more frequently observed in biomarker–drug pairs associated with cancer drugs compared to those for other therapeutic areas (n = 92 (59.7%) vs. n = 62 (40.3%), p < 0.0051). These results suggest that further evidence is needed to support the clinical adoption of pharmacogenomics in non-cancer therapeutic areas. MDPI 2021-03-04 /pmc/articles/PMC8000585/ /pubmed/33806453 http://dx.doi.org/10.3390/jpm11030179 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ). |
spellingShingle | Article Kim, Jeeyun A. Ceccarelli, Rachel Lu, Christine Y. Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020) |
title | Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020) |
title_full | Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020) |
title_fullStr | Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020) |
title_full_unstemmed | Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020) |
title_short | Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020) |
title_sort | pharmacogenomic biomarkers in us fda-approved drug labels (2000–2020) |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8000585/ https://www.ncbi.nlm.nih.gov/pubmed/33806453 http://dx.doi.org/10.3390/jpm11030179 |
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