Jeeyun A. Kim
Research Subjects
Jeeyun A. Kim has a total of 2 co-authors. Here are the top co-authors by number of shared publications:
- Christine Y. Lu
The University of Sydney
1 shared publication - Rachel Ceccarelli
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
1 shared publication
Latest Publications
- Open Access
- 4 March 2021
- Published by MDPI AG in Journal of Personalized Medicine
- Vol. 11 (3) , 179
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 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.
- 4 March 2021
- Published by MDPI AG in Journal of Personalized Medicine
- Vol. 11 (3) , 179
Open AccessPharmacogenomic 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 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.