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...
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| Format: | Article |
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MDPI AG
2021-03-01
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| Series: | Journal of Personalized Medicine |
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| Online Access: | https://www.mdpi.com/2075-4426/11/3/179 |
| _version_ | 1797414561135984640 |
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| author | Jeeyun A. Kim Rachel Ceccarelli Christine Y. Lu |
| author_facet | Jeeyun A. Kim Rachel Ceccarelli Christine Y. Lu |
| author_sort | Jeeyun A. Kim |
| collection | DOAJ |
| 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% (<i>n</i> = 3) in 2000 to 28.2% (<i>n</i> = 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 (<i>n</i> = 92 (59.7%) vs. <i>n</i> = 62 (40.3%), <i>p</i> < 0.0051). These results suggest that further evidence is needed to support the clinical adoption of pharmacogenomics in non-cancer therapeutic areas. |
| first_indexed | 2024-03-09T05:35:06Z |
| format | Article |
| id | doaj.art-02b4d26ef63d4d3fbef3cedf99067eb0 |
| institution | Directory Open Access Journal |
| issn | 2075-4426 |
| language | English |
| last_indexed | 2024-03-09T05:35:06Z |
| publishDate | 2021-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Personalized Medicine |
| spelling | doaj.art-02b4d26ef63d4d3fbef3cedf99067eb02023-12-03T12:28:59ZengMDPI AGJournal of Personalized Medicine2075-44262021-03-0111317910.3390/jpm11030179Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020)Jeeyun A. Kim0Rachel Ceccarelli1Christine Y. Lu2Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USADepartment of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Landmark Center, 401 Park Drive, Suite 401 East, Boston, MA 02215, USADepartment of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Landmark Center, 401 Park Drive, Suite 401 East, Boston, MA 02215, USAPharmacogenomics (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% (<i>n</i> = 3) in 2000 to 28.2% (<i>n</i> = 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 (<i>n</i> = 92 (59.7%) vs. <i>n</i> = 62 (40.3%), <i>p</i> < 0.0051). These results suggest that further evidence is needed to support the clinical adoption of pharmacogenomics in non-cancer therapeutic areas.https://www.mdpi.com/2075-4426/11/3/179pharmacogenomicsprecision medicineUS Food and Drug Administrationclinical actionability |
| spellingShingle | Jeeyun A. Kim Rachel Ceccarelli Christine Y. Lu Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020) Journal of Personalized Medicine pharmacogenomics precision medicine US Food and Drug Administration clinical actionability |
| 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 | pharmacogenomics precision medicine US Food and Drug Administration clinical actionability |
| url | https://www.mdpi.com/2075-4426/11/3/179 |
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