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<\/p>\nBy Emma Kampouraki<\/p>\n
<\/p>\n
Differences in the genetic material we carry make us who we are. Individual variability is important when prescribing drugs, as we can now genotype a person in less than a few hours. We can then use this information to inform drug prescription.\u00a0Genotype-informed prescription is more than virtual reality nowadays. Both FDA\u00a0(US Food and Drug Administration)\u00a0and EMA\u00a0(European Medicines Agency)\u00a0recommend the use of genetic information to drive the decision of treatment and prevent patients from serious mistakes in the prescription of \u201cuseless\u201d drugs.\u00a0Although ethical concerns don\u2019t facilitate the establishment of genotyping in clinical practice, it is common sense that it is also unethical not to use all the existing data for a more informed and safe process of drug therapy. Trial and error is still in place in most drug schemes, however moving on to a more individualised approach has the advantages of costing less and resulting in more effective treatments, increasing patient satisfaction and compliance at the same time.<\/p>\n
The first FDA-approved\u00a0genetically-guided therapy\u00a0was for\u00a0the treatment\u00a0of HER2\u00a0(human epidermal growth factor)\u00a0positive metastatic breast cancers in\u00a01998. The case of\u00a0trastuzumab\u00a0(Herceptin\u00ae) paved the way for the\u00a0co-development of gene-based\u00a0therapies with tests to detect the drug targets, in order to identify the right therapies for the right\u00a0patients.\u00a0Simultaneously with the approval of\u00a0trastuzumab, a\u00a0laboratory technique\u00a0for\u00a0detection of\u00a0HER2 protein overexpression in breast cancer cells\u00a0(Dako\u00a0North America, Inc.\u00a0for\u00a0HercepTest).<\/p>\n
Later, the cases of olaparib (Lynparza\u00ae) and rucaparib (Rubraca\u00ae) prove the increasing need for more targeted therapies and the outstanding interest of medicines regulatory agencies to cover this need as soon as possible.\u00a0Recent findings show that tumours rely on\u00a0poly (ADP-ribose) polymerase (PARP)-mediated DNA repair for their survival. Both\u00a0olaparib\u00a0and\u00a0rucaparib\u00a0are inhibitors of\u00a0the PARP enzymes\u00a0responsible for DNA damage repair.\u00a0In 2014,\u00a0olaparib\u00a0was the first drug in its category to be approved for\u00a0ovarian cancer\u00a0with mutations in BRCA gene, with\u00a0only\u00a0mild to moderate\u00a0adverse\u00a0effects\u00a0to date. In fact, the\u00a0clinical\u00a0trial\u00a0data that convinced the EMA in 2014 for the efficacy of\u00a0olaparib\u00a0were not as convincing for the FDA\u00a0for various reasons.\u00a0A few months later,\u00a0olaparib\u00a0was granted approval in the US.\u00a0Further testing\u00a0on\u00a0humans\u00a0confirmed the increased\u00a0progression-free survival\u00a0for patients with BRCA mutations on\u00a0olaparib.\u00a0Two years later,\u00a0in 2016,\u00a0rucaparib\u00a0became the second drug with accelerated\u00a0approval for treatment of patients with BRCA mutations. In addition, the need for a reliable genetic test to identify patients eligible to receive the treatment was also covered by the FDA. The\u00a0FoundationFocus\u00a0CDxBRCA\u00a0test is\u00a0the first FDA-approved next-generation sequencing (NGS)-based companion diagnostic, which\u00a0detects alterations in\u00a0BRCA\u00a0genes in the tumour tissue of ovarian cancer patients.<\/p>\n
Between the two decades of cancer treatment genotype-based approvals, the first oral anticoagulant warfarin, used for the prevention and treatment of strokes, thrombosis and atrial fibrillation among others,\u00a0was shown to be influenced by genetic variation, as well. Genetic testing prior to prescription along with genotype-guided dosing of warfarin was recommended,\u00a0changing the way we perceive drug dosing.\u00a0Warfarin is one of the most commonly prescribed drugs, with\u00a0more than 2 million people\u00a0are\u00a0treated with warfarin\u00a0every year in the US,\u00a0hence\u00a0the importance of such advancement is great, as it affects the clinical management of millions of people worldwide.<\/p>\n
The list of drugs that receive approval\u00a0and are specifically designed for variant\u00a0genotypic characteristics is fast growing.\u00a0It is our responsibility\u00a0to\u00a0educate health professionals and most of all patients. Now, more than ever, we need to\u00a0find the best way to use and protect genetic information, while at the same time\u00a0proving\u00a0its power\u00a0to\u00a0change\u00a0clinical practice forever.<\/p>\n","protected":false},"excerpt":{"rendered":"
By Emma Kampouraki Differences in the genetic material we carry make us who we are. Individual variability is important when prescribing drugs, as we can now genotype a person in less than a few hours. We can then use this information to inform drug prescription.\u00a0Genotype-informed prescription is more than virtual reality nowadays. Both FDA\u00a0(US Food […]<\/p>\n","protected":false},"author":7176,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,7],"tags":[],"class_list":["post-193","post","type-post","status-publish","format-standard","hentry","category-archive","category-emma"],"_links":{"self":[{"href":"https:\/\/blogs.ncl.ac.uk\/react\/wp-json\/wp\/v2\/posts\/193","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.ncl.ac.uk\/react\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.ncl.ac.uk\/react\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.ncl.ac.uk\/react\/wp-json\/wp\/v2\/users\/7176"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.ncl.ac.uk\/react\/wp-json\/wp\/v2\/comments?post=193"}],"version-history":[{"count":3,"href":"https:\/\/blogs.ncl.ac.uk\/react\/wp-json\/wp\/v2\/posts\/193\/revisions"}],"predecessor-version":[{"id":316,"href":"https:\/\/blogs.ncl.ac.uk\/react\/wp-json\/wp\/v2\/posts\/193\/revisions\/316"}],"wp:attachment":[{"href":"https:\/\/blogs.ncl.ac.uk\/react\/wp-json\/wp\/v2\/media?parent=193"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.ncl.ac.uk\/react\/wp-json\/wp\/v2\/categories?post=193"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.ncl.ac.uk\/react\/wp-json\/wp\/v2\/tags?post=193"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}