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Article

Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020)

1
Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA
2
Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Landmark Center, 401 Park Drive, Suite 401 East, Boston, MA 02215, USA
*
Author to whom correspondence should be addressed.
Academic Editor: Laura Scheinfeldt
J. Pers. Med. 2021, 11(3), 179; https://doi.org/10.3390/jpm11030179
Received: 20 January 2021 / Revised: 21 February 2021 / Accepted: 26 February 2021 / Published: 4 March 2021
(This article belongs to the Special Issue Pharmacogenomics: From Basic Research to Clinical Implementation)
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 [email protected] 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. View Full-Text
Keywords: pharmacogenomics; precision medicine; US Food and Drug Administration; clinical actionability pharmacogenomics; precision medicine; US Food and Drug Administration; clinical actionability
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MDPI and ACS Style

Kim, J.A.; Ceccarelli, R.; Lu, C.Y. Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020). J. Pers. Med. 2021, 11, 179. https://doi.org/10.3390/jpm11030179

AMA Style

Kim JA, Ceccarelli R, Lu CY. Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020). Journal of Personalized Medicine. 2021; 11(3):179. https://doi.org/10.3390/jpm11030179

Chicago/Turabian Style

Kim, Jeeyun A., Rachel Ceccarelli, and Christine Y. Lu. 2021. "Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000–2020)" Journal of Personalized Medicine 11, no. 3: 179. https://doi.org/10.3390/jpm11030179

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