Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs

Vivot, Alexandre; Boutron, Isabelle; Ravaud, Philippe; Porcher, Raphaël

doi:10.1038/gim.2014.181

Cited by 34 publications

(27 citation statements)

References 30 publications

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“…Rigor towards genetic testing before oncology drug treatment in Hungary may be caused by the high cost of these target molecules, therefore confirmation of efficacy is rather obligatory before treatment. However, the proportion of requirement or recommendation for PGx testing is higher in oncology than in other therapeutic areas in the United States [15]. Of note, FDA offers more applicable information about dose modifications than Hungarian SmPCs.…”

Section: Discussionmentioning

confidence: 99%

Pharmacogenomic biomarker information differences between drug labels in the United States and Hungary: implementation from medical practitioner view

et al. 2019

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Pharmacogenomic biomarker availability of Hungarian Summaries of Product Characteristics (SmPC) was assembled and compared with the information in US Food and Drug Administration (FDA) drug labels of the same active substance (July 2019). The level of action of these biomarkers was assessed from The Pharmacogenomics Knowledgebase database. From the identified 264 FDA approved drugs with pharmacogenomic biomarkers in drug label, 195 are available in Hungary. From them, 165 drugs include pharmacogenomic data disposing 222 biomarkers. Most of them are metabolizing enzymes (46%) and pharmacological targets (41%). The most frequent therapeutic area is oncology (37%), followed by infectious diseases (12%) and psychiatry (9%) (p < 0.00001). Most common biomarkers in Hungarian SmPCs are CYP2D6, CYP2C19, estrogen and progesterone hormone receptor (ESR, PGS). Importantly, US labels present more specific pharmacogenomic subheadings, the level of action has a different prominence, and offer more applicable dose modifications than Hungarians (5% vs 3%). However, Hungarian SmPCs are at 9 oncology drugs stricter than FDA, testing is obligatory before treatment. Out of the biomarkers available in US drug labels, 62 are missing completely from Hungarian SmPCs (p < 0.00001). Most of these belong to oncology (42%) and in case of 11% of missing biomarkers testing is required before treatment. In conclusion, more factual, clear, clinically relevant pharmacogenomic information in Hungarian SmPCs would reinforce implementation of pharmacogenetics. Underpinning future perspective is to support regulatory stakeholders to enhance inclusion of pharmacogenomic biomarkers into Hungarian drug labels and consequently enhance personalized medicine in Hungary.

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Section: Discussionmentioning

confidence: 99%

Pharmacogenomic biomarker information differences between drug labels in the United States and Hungary: implementation from medical practitioner view

et al. 2019

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“…Many times, patients end up paying themselves for the test to avoid the odyssey of the process [107]. Even after recent revisions of several drug labels by the FDA, now including relevant pharmacogenetic information on them, most of these drugs are not required genetic testing before initiating therapy [108]. Consequently, insurance companies will often refuse to pay for genetic testing indicating a lack of directive Citation: Oates JT, Lopez D. Pharmacogenetics: An Important Part of Drug Development with a Focus on Its Application.…”

Section: Implementation Of Pharmacogeneticsmentioning

confidence: 99%

“…Consequently, insurance companies will often refuse to pay for genetic testing indicating a lack of directive Citation: Oates JT, Lopez D. Pharmacogenetics: An Important Part of Drug Development with a Focus on Its Application. Int J Biomed Investig 2018; 1: 111. doi: 10.31531/2581-4745.1000111 regarding whether a genetic test is required or not (108). Therefore, new policies are necessary to expand the use of genetic testing in healthcare settings (108).…”

Section: Implementation Of Pharmacogeneticsmentioning

confidence: 99%

Pharmacogenetics: An Important Part of Drug Development with A Focus on Its Application

Oates¹,

Lopez²

2018

Int J Biomed Investig

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Since the human genome project in 2003, the view of personalized medicine to improve diagnosis and cure diseases at the molecular level became more real. Sequencing the human genome brought some benefits in medicine such as early detection of diseases with a genetic predisposition, treating patients with rare diseases, the design of gene therapy and the understanding of pharmacogenetics in the metabolism of drugs. This review explains the concepts of pharmacogenetics, polymorphisms, mutations, variations, and alleles, and how this information has helped us better understand the metabolism of drugs. Multiple resources are presented to promote reducing the gap between scientists, physicians, and patients in understanding the use and benefits of pharmacogenetics. Some of the most common clinical examples of genetic variants and how pharmacogenetics was used to determine treatment options for patients having these variants were discussed. Finally, we evaluated some of the challenges of implementing pharmacogenetics in a clinical setting and proposed actions to be taken to make pharmacogenetics a standard diagnostic tool in personalized medicine.

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“…30 From the Drugs@FDA database we extracted the date of the drug's approval, the date of the first label containing pharmacogenomic information, the first indication for the drug and, if different, the first indication for the drug with pharmacogenomic labeling, and the date the drug's sponsor submitted the application to the regulation agency, as previously described. 5 From the European Medicines Agency (EMA) website we obtained the date of marketing authorization valid throughout the European Union and the date of submission of the application to the agency. We considered the first submission of an application to the FDA or EMA as a proxy for the end of drug development, and the first approval of the drug by one agency as the start of drug marketing.…”

Section: Data Extractionmentioning

confidence: 99%

“…Currently, the labels of 140 US Food and Drug Administration (FDA)-approved drugs mention a pharmacogenomic biomarker, one-third of which are indicated in oncology. 5 A drug that has been tested only in a biomarker-positive subpopulation would have an implicit requirement for genetic testing, 5,6 and one may consider that a high-quality trial with only biomarker-positive patients (i.e., an enriched trial) corresponds with an acceptable level of evidence for targeted therapies. 7,8 Nonetheless, if no clinical data are available for biomarker-negative patients, the use of a biomarker to restrict treatment to a subgroup of patients may not be relevant, as noted by several regulatory agencies.…”

Section: Introductionmentioning

confidence: 99%

Pharmacogenomic biomarkers as inclusion criteria in clinical trials of oncology-targeted drugs: a mapping of ClinicalTrials.gov

Vivot

Zeitoun

et al. 2016

Genetics in Medicine

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Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs

Cited by 34 publications

References 30 publications

Pharmacogenomic biomarker information differences between drug labels in the United States and Hungary: implementation from medical practitioner view

Pharmacogenomic biomarker information differences between drug labels in the United States and Hungary: implementation from medical practitioner view

Pharmacogenetics: An Important Part of Drug Development with A Focus on Its Application

Pharmacogenomic biomarkers as inclusion criteria in clinical trials of oncology-targeted drugs: a mapping of ClinicalTrials.gov

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