ArticleGenetics in medicine : official journal of the American College of Medical Genetics2015
Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs.
Article in Genetics in medicine : official journal of the American College of Medical Genetics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02458040 (Clinical Benefit of Genetic Biomarkers for Guiding Treatment Decisions in Oncology Drugs), which is not on this map. Cited by 20 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Clinical Benefit of Genetic Biomarkers for Guiding Treatment Decisions in Oncology Drugs
Who cites it
20 citing papers in PubMed.
- Knowledge, attitudes, and perceptions of pharmacogenetic testing in swiss community pharmacies: a mixed-methods study among physicians, pharmacists, and the general public.Frontiers in pharmacology · 2026Article
- From Drug Discovery to Drug Approval: A Comprehensive Review of the Pharmacogenomics Status Quo with a Special Focus on Egypt.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Transcriptional regulation of genetic variants in theThe Korean journal of physiology & pharmacology : official journal of the Korean Physiological Society and the Korean Society of Pharmacology · 2024Article
- Pharmacogenomic biomarker information on drug labels of the Spanish Agency of Medicines and Sanitary products: evaluation and comparison with other regulatory agencies.The pharmacogenomics journal · 2024Article
- Real-World Evaluation of a Population Germline Genetic Screening Initiative for Family Medicine Patients.Journal of personalized medicine · 2022Article
- Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection.Therapeutic innovation & regulatory science · 2022Article
- Real-World Evaluation of Universal Germline Screening for Cancer Treatment-Relevant Pharmacogenes.Cancers · 2021Article
- Pharmacogenomic Biomarkers in US FDA-Approved Drug Labels (2000-2020).Journal of personalized medicine · 2021Article
- A Web-Based Pharmacogenomics Search Tool for Precision Medicine in Perioperative Care.Journal of personalized medicine · 2020Article
- Pharmacogenomic biomarker information differences between drug labels in the United States and Hungary: implementation from medical practitioner view.The pharmacogenomics journal · 2020Article
- Evidence to Support Inclusion of Pharmacogenetic Biomarkers in Randomised Controlled Trials.Journal of personalized medicine · 2019Review
- Pharmacogenomic potential in advanced cancer patients.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2019Observational
- Use of Pharmacogenetic Drugs by the Dutch Population.Frontiers in genetics · 2019Article
- Pharmacogenetics: An Important Part of Drug Development with A Focus on Its Application.International journal of biomedical investigation · 2018Article
- Comparing cytochrome P450 pharmacogenetic information available on United States drug labels and European Union Summaries of Product Characteristics.The pharmacogenomics journal · 2017Article
- Characterizing Pharmacogenomic-Guided Medication Use With a Clinical Data Repository.Clinical pharmacology and therapeutics · 2017Article
- Evidence for Treatment-by-Biomarker interaction for FDA-approved Oncology Drugs with Required Pharmacogenomic Biomarker Testing.Scientific reports · 2017Article
- Integrating pharmacogenetic testing into primary care.Expert review of precision medicine and drug development · 2017Article
- Pharmacogenomic biomarkers as inclusion criteria in clinical trials of oncology-targeted drugs: a mapping of ClinicalTrials.gov.Genetics in medicine : official journal of the American College of Medical Genetics · 2016Article
- Potential utility of precision medicine for older adults with polypharmacy: a case series study.Pharmacogenomics and personalized medicine · 2016Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe aim of this study was to compare guidance for genetic testing in US Food and Drug Administration (FDA)-approved drug labels in oncology to those of drugs for other therapeutic areas.
methodsWe reviewed labels of all the FDA-approved drugs with labels containing pharmacogenomic information. We assessed whether genetic testing was required or recommended before prescription and, if not, the reason for pharmacogenomic labeling.
resultsWe included 140 drugs corresponding to 158 drug-biomarker pairs. Overall, 46 (29%) of 158 pairs stated a requirement or recommendation for genetic biomarker testing in the label. This proportion was higher in oncology than in other areas (62 vs. 12%; P < 0.001). For the 112 drug-biomarker pairs (including 20 in oncology) without recommendation or requirement for genetic testing, the main reasons for pharmacogenomic labeling were change in pharmacologic end points (32%) and higher risk of toxicity (30%). For 11 (10%) pairs (including 1 in oncology), a genetic biomarker was mentioned only to inform that it was not relevant. In oncology, the main reasons for pharmacogenomic labeling were higher risk of toxicity (55%) and definition of the mechanism of action (25%).
conclusionInclusion of biomarkers in drug labels does not always correspond to required or recommended genetic testing, especially outside oncology.Genet Med 17 9, 733-738.
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