{"id":13455,"date":"2020-01-30T11:20:11","date_gmt":"2020-01-30T11:20:11","guid":{"rendered":"http:\/\/evaggelatos.com\/?p=13455"},"modified":"2020-01-30T11:20:32","modified_gmt":"2020-01-30T11:20:32","slug":"%ce%b5%cf%80%ce%b9%cf%84%ce%ad%ce%bb%ce%bf%cf%85%cf%82-%cf%84%ce%bf-food-and-drug-administration-fda-%ce%b1%cf%80%ce%bf%ce%b4%ce%ad%cf%87%ce%b5%cf%84%ce%b1%ce%b9-%ce%b1%cf%80%cf%8c-%cf%84%ce%bf-2017","status":"publish","type":"post","link":"https:\/\/evaggelatos.com\/?p=13455","title":{"rendered":"\u0395\u03c0\u03b9\u03c4\u03ad\u03bb\u03bf\u03c5\u03c2 \u03c4\u03bf Food and Drug Administration (FDA) \u03b1\u03c0\u03bf\u03b4\u03ad\u03c7\u03b5\u03c4\u03b1\u03b9 \u03b1\u03c0\u03cc \u03c4\u03bf 2017 \u03c4\u03b7\u03bd \u03b3\u03bf\u03bd\u03b9\u03b4\u03b9\u03b1\u03ba\u03ae \u03b8\u03b5\u03c1\u03b1\u03c0\u03b5\u03af\u03b1 \u03c3\u03c4\u03bf\u03c5\u03c2 \u03ba\u03b1\u03c1\u03ba\u03af\u03bd\u03bf\u03c5\u03c2 \u03ba\u03b1\u03b9 \u03ac\u03bb\u03bb\u03b5\u03c2 \u03bd\u03cc\u03c3\u03bf\u03c5\u03c2"},"content":{"rendered":"<h1 class=\"blog-title col-md-8\">FDA approves first cancer treatment based on genetic makeup, not tumor location<\/h1>\n<div class=\"blog-post-row\">\n<p><time class=\"timestamp caption-gray col-md-8\"> \u0391\u03c5\u03b3\u03bf\u03cd\u03c3\u03c4\u03bf\u03c5 01, 2017<\/time><\/p>\n<article class=\"col-md-8\">\n<figure>\n<div class=\"video-container video-image\"><img decoding=\"async\" class=\"hero-img-blog\" src=\"https:\/\/cdn.cancercenter.com\/-\/media\/ctca\/images\/others\/blogs\/2017\/08-august\/02-blog-immunotherapy-drug-l.jpg?h=630&amp;la=en&amp;w=1200&amp;hash=B6A35D0D07D3940F73647201882F26D5\" alt=\"immunotherapy drug\" \/><\/div><figcaption class=\"caption-figure\">The U.S. Food and Drug has made the breakthrough step of approving a cancer therapy based not on the tumor&#8217;s primary location, but on a specific genetic feature found in the cancer\u2019s DNA.<\/figcaption><\/figure>\n<div class=\"blog-content\">\n<p>Cancer has traditionally been identified by where in the body it develops. <a href=\"https:\/\/www.cancercenter.com\/cancer-types\/breast-cancer\">Breast cancer<\/a>\u00a0forms in the breast, <a href=\"https:\/\/www.cancercenter.com\/cancer-types\/lung-cancer\">lung cancer<\/a>\u00a0in the lungs, and so on. Even when a cancer metastasizes to a different part of the body, it is defined by its original location. If <a href=\"https:\/\/www.cancercenter.com\/cancer-types\/colorectal-cancer\">colorectal cancer<\/a>\u00a0travels to the brain, for instance, it is called metastatic colorectal cancer, not <a href=\"https:\/\/www.cancercenter.com\/cancer-types\/brain-cancer\">brain cancer<\/a>. But many doctors, including <a href=\"https:\/\/www.cancercenter.com\/physician-directory\/shayma-master-kazmi\">Shayma Master Kazmi, MD, RPh<\/a>,\u00a0Medical Oncologist at our <a href=\"https:\/\/www.cancercenter.com\/locations\/philadelphia\">hospital in Philadelphia<\/a>, call that old-school thinking. <span style=\"font-size: 14pt;\"><strong>&#8220;We used to just think about cancers in terms of where they originated,&#8221; Dr. Kazmi says. &#8220;Now we\u2019re expanding our views on cancer to not be limited by where it starts, but to look at its blueprint, the way the cancer metastasizes, the way it grows, what makes the cancers tick.&#8221;<\/strong><\/span><\/p>\n<h2>Breakthrough treatment<\/h2>\n<p>The U.S. Food and Drug Administration (FDA) supported that perspective in May, when it made the <a href=\"https:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm560167.htm\" target=\"_blank\" rel=\"noopener noreferrer\">breakthrough step<\/a> of approving a cancer therapy based not on the tumor&#8217;s primary location but on a specific genetic feature found in the cancer\u2019s DNA. The approval allows the <a href=\"https:\/\/www.cancercenter.com\/treatment-options\/precision-medicine\/immunotherapy\/checkpoint-inhibitors\">checkpoint inhibitor<\/a>\u00a0drug pembrolizumab (Keytruda<sup>\u00ae<\/sup>) to be used to treat patients with inoperable metastatic tumors that have one of two specific genetic features, called microsatellite instability-high (MSI-H) and mismatch repair deficiency (dMMR). These gene mutations make it difficult for the DNA in a cell to repair itself, which may lead to the type of unchecked cell growth that causes many tumors to form and grow. The decision marked the first time in its history the FDA approved a cancer treatment based on a genetic feature. \u201cThis critically important and paradigm-changing decision by the FDA is one more example of how future cancer treatments will be determined,&#8221; says <a href=\"https:\/\/www.cancercenter.com\/physician-directory\/maurie-markman\">Maurie Markman, MD<\/a>, president of Medicine &amp; Science at Cancer Treatment Centers of America<sup>\u00ae<\/sup> (CTCA).<\/p>\n<p>Checkpoint inhibitors like pembrolizumab are <a href=\"https:\/\/www.cancercenter.com\/treatment-options\/precision-medicine\/immunotherapy\">immunotherapy<\/a>\u00a0drugs designed to disrupt the communication, common between some cancer cells and <a href=\"https:\/\/www.cancercenter.com\/community\/blog\/2017\/05\/whats-the-difference-b-cells-and-t-cells\">disease-fighting T-cells<\/a>, that allows cancer to hide from the immune system. Immune cells are almost like the body\u2019s police force, scanning other cells as they pass certain checkpoints to determine whether they pose a threat that needs to be neutralized, like an infection or disease. But because cancer is made of the body\u2019s own cells gone awry, some cancer cells are able to mask their threat, by sending deceptive signals to protein receptors, located on the immune cells\u2019 surface, as they pass the checkpoints. Checkpoint inhibitors are so named because they work by blocking those receptors and exposing the cancer as harmful and ripe for attack. If not for these checkpoints, the immune system may attack healthy cells. The goal with checkpoint inhibitors is to keep those healthy cell protections intact while empowering the immune system to recognize cancer\u2019s threat. But they don\u2019t always work as designed, and scientists are still trying to figure out why.<\/p>\n<h2>&#8216;Huge first step&#8217;<\/h2>\n<p>&#8220;These drugs release the brake on the immune system so our T-cells can look for a foreign antigen,&#8221; Dr. Markman says. &#8220;The question is: What&#8217;s in the tumor cells that they will find when they release the brake? What are they attacking?&#8221; Pembrolizumab, for example, yields positive results about 20 percent of the time it\u2019s used. While researchers don\u2019t know why it works in <a href=\"https:\/\/www.cancercenter.com\/community\/blog\/2017\/02\/why-does-immunotherapy-work-for-some-but-not-others\">some patients but not others<\/a>, what they have discovered is that the MSI-H and\/or dMMR defects are present in cancers in which the drug has shown positive results, regardless of where the tumor is located. In fact, these defects have been found in a number of patients, across cancer types. MSI-H has been detected in <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC3037515\/\" target=\"_blank\" rel=\"noopener noreferrer\">15 percent of all colorectal tumors<\/a>, as well as patients with bladder, breast, prostate and thyroid cancers. The defect has also been found in 90 percent of colorectal cancers in patients with Lynch syndrome, a genetic condition that elevates the risk for some cancers.<\/p>\n<p>So far, the FDA has approved checkpoint inhibitors to treat several cancers, but only based on where they formed in the body\u2014in the lung, <a href=\"https:\/\/www.cancercenter.com\/cancer-types\/bladder-cancer\">bladder<\/a>\u00a0and <a href=\"https:\/\/www.cancercenter.com\/cancer-types\/kidney-cancer\">kidney<\/a>, for example. The drugs are also approved to treat <a href=\"https:\/\/www.cancercenter.com\/cancer-types\/hodgkin-lymphoma\">Hodgkin lymphoma<\/a>\u00a0and metastatic <a href=\"https:\/\/www.cancercenter.com\/cancer-types\/melanoma\">melanoma<\/a>. Dr. Kazmi says that by basing this new approval solely on a cancer&#8217;s specific genetic feature, the FDA is taking &#8220;the first huge step&#8221; in changing how cancer may be treated in the future. &#8220;It is very exciting that the FDA is being so forward thinking by changing its views on traditional cancer treatment,&#8221; she says. &#8220;We do not want to be limited by the origin of the cancer. We want to attack it at its core, its driving mechanism.&#8221;<\/p>\n<p><a href=\"https:\/\/www.cancercenter.com\/community\/blog\/2017\/02\/why-does-immunotherapy-work-for-some-but-not-others\">\u03a0\u0397\u0393\u0397: https:\/\/www.cancercenter.com\/community\/blog\/2017\/08\/fda-approves-first-cancer-treatment-based-on-genetic-makeup-not-tumor-location<\/a><\/p>\n<\/div>\n<\/article>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>FDA approves first cancer treatment based on genetic makeup, not tumor location \u0391\u03c5\u03b3\u03bf\u03cd\u03c3\u03c4\u03bf\u03c5 01, 2017 The U.S. Food and Drug has made the breakthrough step of approving a cancer therapy based not on the tumor&#8217;s primary location, but on a specific genetic feature found in the cancer\u2019s DNA. Cancer has traditionally been identified by where &hellip; <\/p>\n<p><a class=\"more-link btn\" href=\"https:\/\/evaggelatos.com\/?p=13455\">\u03a3\u03c5\u03bd\u03ad\u03c7\u03b5\u03b9\u03b1 \u03b1\u03bd\u03ac\u03b3\u03bd\u03c9\u03c3\u03b7\u03c2<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[85,42],"tags":[196],"class_list":["post-13455","post","type-post","status-publish","format-standard","hentry","category-85","category-42","tag-196","item-wrap"],"_links":{"self":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts\/13455","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=13455"}],"version-history":[{"count":2,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts\/13455\/revisions"}],"predecessor-version":[{"id":13457,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=\/wp\/v2\/posts\/13455\/revisions\/13457"}],"wp:attachment":[{"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=13455"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=13455"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/evaggelatos.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=13455"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}