{"id":4053,"date":"2019-09-17T17:09:45","date_gmt":"2019-09-17T08:09:45","guid":{"rendered":"http:\/\/163.180.4.222\/lab\/?p=4053"},"modified":"2019-09-17T17:09:45","modified_gmt":"2019-09-17T08:09:45","slug":"%ec%95%94%ec%a2%85-%ea%b0%80%eb%a6%ac%ec%a7%80-%ec%95%8a%eb%8a%94-%eb%a7%8c%eb%8a%a5%ed%95%ad%ec%95%94%ec%a0%9c-%eb%a1%9c%ec%8a%88%ec%9d%98-%eb%a1%9c%ec%a6%90%eb%a6%ac%ed%8a%b8%eb%a0%89-fda","status":"publish","type":"post","link":"https:\/\/biochemistry.khu.ac.kr\/lab\/?p=4053","title":{"rendered":"\uc554\uc885 \uac00\ub9ac\uc9c0 \uc54a\ub294 &#8216;\ub9cc\ub2a5\ud56d\uc554\uc81c&#8217; \ub85c\uc288\uc758 \ub85c\uc990\ub9ac\ud2b8\ub809 FDA \ud488\ubaa9\ud5c8\uac00"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><strong class=\"summary_view\" data-translation=\"\">\ud2b9\uc815 \uc885\uc591\uc774 \uc544\ub2cc \ud2b9\uc815 \uc720\uc804\uc790\uc5d0 \ubaa9\ud45c..\ub2e4\uc591\ud55c \uc885\uc591\uc5d0 \uc801\uc6a9\uac00\ub2a5<br \/>\n\uc804\uc774\uc131 \ube44\uc18c\uc138\ud3ec\ud3d0\uc554\uc5d0\ub3c4 \uc2b9\uc778..\uad6d\ub0b4\uc5d0\uc11c\ub3c4 \ud76c\uadc0\uc758\uc57d\ud488 \uc9c0\uc815<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<div id=\"harmonyContainer\" class=\"article_view\" data-translation-body=\"\">\n<section>\n<figure class=\"figure_frm origin_fig\">\n<p class=\"link_figure\"><img decoding=\"async\" class=\"thumb_g_article\" src=\"https:\/\/img3.daumcdn.net\/thumb\/R658x0.q70\/?fname=https:\/\/t1.daumcdn.net\/news\/201908\/17\/NEWS1\/20190817070205105bjnd.jpg\" alt=\"\u00a9 \ub274\uc2a41\" width=\"658\" height=\"auto\" \/><\/p><figcaption class=\"txt_caption default_figure\"><\/figcaption><\/figure>\n<p>&nbsp;<\/p>\n<p>\ubbf8\uad6d\uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uc774 \uc554\uc885\uc5d0 \uc0c1\uad00\uc5c6\uc774 \ud2b9\uc815 \uc720\uc804\uc790\ub97c \ubaa9\ud45c\ub85c \ud55c \ud45c\uc801\ud56d\uc554\uce58\ub8cc\uc81c &#8216;\ub85c\uc990\ub9ac\ud2b8\ub809'(\uc131\ubd84 \uc5d4\ud2b8\ub809\ud2f0\ub2d9)\uc744 \uc2b9\uc778\ud588\ub2e4. FDA\ub294 \ud601\uc2e0\uc801\uc778 \uc720\uc804\uc790 \ud45c\uc801\ud56d\uc554\uc81c \uac1c\ubc1c\uc744 \uc7a5\ub824\ud55c\ub2e4\uace0 \ubc1d\ud600 \ud5a5\ud6c4 \uc720\uc804\uc790 \ud45c\uc801\ud56d\uc554\uc81c\uc5d0 \ub300\ud55c \ud488\ubaa9\ud5c8\uac00\uac00 \uc99d\uac00\ud560 \uac83\uc73c\ub85c \ubcf4\uc778\ub2e4.<\/p>\n<p>FDA\ub294 \uc9c0\ub09c 15\uc77c(\ud604\uc9c0\uc2dc\uac04) \uce58\ub8cc\ubc95\uc774 \uc5c6\ub294 \uc2e0\uacbd\uc131 \ud2f0\ub85c\uc2e0\uc218\uc6a9\uccb4\ud0a4\ub098\uc81c(NTRK) \uc735\ud569 \uc720\uc804\uc790\ub97c \uac00\uc9c4 \uc131\uc778 \ubc0f \uccad\uc18c\ub144 \uc554\ud658\uc790\ub97c \ub300\uc0c1\uc73c\ub85c \ud55c \ub85c\uc990\ub9ac\ud2b8\ub809\uc5d0 \ub300\ud574 \uc2e0\uc18d \uc2b9\uc778\ud588\ub2e4. \ub85c\uc990\ub9ac\ud2b8\ub809\uc740 \uc2a4\uc704\uc2a4\uc5d0 \ubcf8\uc0ac\ub97c \ub454 \ub2e4\uad6d\uc801 \uc81c\uc57d\uc0ac \ub85c\uc288\uc758 \uc77c\uc6d0\uc778 \uc81c\ub128\ud14d\uc774 \uac1c\ubc1c\ud55c \ud45c\uc801\ud56d\uc554\uc81c\ub85c \uc774\ubc88 FDA\uc2b9\uc778\uc740 \uc9c0\ub09c6\uc6d4 \uc77c\ubcf8 \ud6c4\uc0dd\ub178\ub3d9\uc131(MHLW)\uc5d0 \uc774\uc740 \ub450\ubc88\uc9f8 \ud488\ubaa9\ud5c8\uac00\ub2e4.<\/p>\n<p>\uc774\ubc88 \ud5c8\uac00\uc5d0 \ub300\ud574 \ub124\ub4dc \uc0e4\ud50c\ub9ac\uc2a4 FDA\uad6d\uc7a5 \ub300\ud589\uc740 &#8220;\uc554 \uc870\uc9c1\uacfc \ubb34\uad00\ud558\uac8c \uce58\ub8cc\uac00 \uac00\ub2a5\ud55c \ud601\uc2e0\uc801\uc774\uace0\ub3c4 \ud765\ubbf8\ub85c\uc6b4 \uc2dc\ub300\uac00 \uc5f4\ub838\ub2e4&#8221;\uba70 &#8220;\uc815\ud655\ud55c \uc57d\ubb3c\uc804\ub2ec\uc774 \uac00\ub2a5\ud55c \ud6a8\uacfc\uc801\uc778 \uc2e0\uc57d\uac1c\ubc1c\uc744 \uc704\ud574 \ubc14\uc774\uc624\ub9c8\ucee4 \ud65c\uc6a9\uc774 \ubc1c\uc804\ud558\uace0 \uc788\ub2e4&#8221;\uace0 \uc124\uba85\ud588\ub2e4. \ub610\ud55c &#8220;\uc2e0\uc18d\uc2b9\uc778 \uc808\ucc28\ub97c \ud1b5\ud574 \uc815\ubc00\ud558\uace0 \ud6a8\uacfc\uc801\uc778 \ud45c\uc801\ud56d\uc554\uc81c \uac1c\ubc1c\uc744 \uc9c0\uc6d0\ud55c\ub2e4&#8221;\uba70 \uc554\uce58\ub8cc\uc640 \uae30\ud0c0 \uc804\ubc18\uc801\uc778 \uc9c8\ubcd1 \uc720\ud615\uc5d0 \uac78\ucc98 \ud45c\uc801\ud654\ub41c \ud601\uc2e0\uc744 \uc7a5\ub824\ud558\uae30 \uc704\ud574 \uc804\ub150\ud558\uace0 \uc788\ub2e4&#8221;\uace0 \ub367\ubd99\uc600\ub2e4.<\/p>\n<p>FDA\uac00 \ud2b9\uc815 \uc885\uc591\uc774 \uc544\ub2cc \uc77c\ubc18\uc801\uc778 \ubc14\uc774\uc624\ub9c8\ucee4\ub97c \ubaa9\ud45c\ub85c \ud558\ub294 \ud56d\uc554\uc81c\uc5d0 \ud488\ubaa9\ud5c8\uac00\ub97c \ub0b4\uc900 \uac83\uc740 \uc774\ubc88\uc774 \uc138\ubc88\uc9f8\ub2e4. \uc774\ubc88 \uc2b9\uc778\uc740 FDA\uac00 \uc2b9\uc778\ud55c &#8216;\uc870\uc9c1\uc5d0 \uad6c\uc560\ubc1b\uc9c0 \uc54a\ub294&#8217; \ud56d\uc554\uc81c\ub85c \uc9c0\ub09c 2018\ub144 10\uc6d4 \ubc1c\ud45c\ud55c \ud45c\uc801\uce58\ub8cc\uc81c \uac1c\ubc1c\uc5d0 \uad00\ud55c \uac00\uc774\ub4dc\uc5d0 \ub530\ub978 \uac83\uc73c\ub85c \ubcf4\uc778\ub2e4. \uc55e\uc11c 2017\ub144\uc5d0 \uace0\ube48\ub3c4 \ud604\ubbf8\ubd80\uc218\uccb4\ubd88\uc548\uc815(MSI-H) \uc720\uc804\uc790 \ub610\ub294 \ubcf5\uc81c\uc2e4\uc218\uad50\uc815\uacb0\ud54d(dMMR) \uc720\uc804\uc790\uac00 \uc788\ub294 \ud658\uc790\uc5d0 \ub300\ud574 &#8216;\ud0a4\ud2b8\ub8e8\ub2e4'(\uc131\ubd84 \ud3a8\ube0c\ub864\ub9ac\ub9d9)\uc744 \uc2b9\uc778\ud588\uace0, 2018\ub144\uc5d0\ub294 NTRK \uc720\uc804\uc790\uac00 \ud655\uc778\ub41c \ud658\uc790\uc5d0 \ub300\ud574 &#8216;\ube44\ud2b8\ub77d\ube44'(\uc131\ubd84 \ub77c\ub85c\ud2b8\ub809\ud2f0\ub2d9)\ub97c \ud5c8\uac00\ud588\ub2e4.<\/p>\n<p>\ubbf8\uad6d \uba38\ud06c\uac00 \ubcf4\uc720\ud55c \ud0a4\ud2b8\ub8e8\ub2e4\ub294 \ub2e4\uc591\ud55c \uc801\uc751\uc99d \ud655\ubcf4\ub85c \uc62c\ud574 \uc0c1\ubc18\uae30\uc5d0\ub9cc 1\uc5b54000\ub9cc\ub2ec\ub7ec(\uc57d 1696\uc5b5\uc6d0) \ub9e4\ucd9c\uc744 \uc62c\ub9b0 \ube14\ub85d\ubc84\uc2a4\ud130 \ud56d\uc554\uc81c\ub2e4. \ube14\ub984\ubc84\uadf8\ub294 2023\ub144 \ud0a4\ud2b8\ub8e8\ub2e4 \ub9e4\ucd9c\uc744 193\uc5b5\ub2ec\ub7ec(\uc57d 22\uc8707855\uc5b5\uc6d0)\ub85c \uba38\ud06c \uc804\uccb4 \ub9e4\ucd9c\uc758 37%\ub97c \ucc28\uc9c0\ud560 \uac83\uc73c\ub85c \uc608\uc0c1\ud588\ub2e4. \ubc18\uba74 \ubc14\uc774\uc5d8\uc0ac\uc758 \ube44\ud2b8\ub77d\ube44\ub294 \uc9c0\ub09c\ub2ec 26\uc77c \uc720\ub7fd\uc758\uc57d\uccad(EMA)\uc73c\ub85c\ubd80\ud130 \uc2b9\uc778\uad8c\uace0\ub97c \ubc1b\ub294 \ub4f1 \uc544\uc9c1 \ubbf8\uad6d \uc678 \uc8fc\uc694\uc2dc\uc7a5\uc5d0\uc11c \ubcf8\uaca9\uc801\uc778 \ub9e4\ucd9c\uc774 \ubc1c\uc0dd\ud558\uc9c0 \uc54a\uc740 \uc0c1\ud0dc\ub2e4.<\/p>\n<p>FDA\ub294 NTRK \uc720\uc804\uc790 \uc591\uc131\uc778 \uc554\ud658\uc790 54\uba85\uc744 \ub300\uc0c1\uc73c\ub85c \uc9c4\ud589\ub41c 4\uac74\uc758 \uc784\uc0c1\uc2dc\ud5d8\uc744 \ud1a0\ub300\ub85c \ud3c9\uac00\ud588\ub2e4. \uc2dc\ud5d8\uacb0\uacfc \uac1d\uad00\uc801\ubc18\uc751\ub960(ORR)\uc740 57%\ub85c 7.4%\uc5d0\uc11c\ub294 \uc644\uc804 \uc18c\uba78\ub410\ub2e4. \uce58\ub8cc\uc5d0 \ubc18\uc751\uc744 \ubcf4\uc778 \ud658\uc790 31\uba85 \uc911 61%\ub294 9\uac1c\uc6d4 \uc774\uc0c1 \uc885\uc591\uc774 \uc904\uc5b4\ub4e0 \uac83\uc73c\ub85c \ud655\uc778\ub410\ub2e4. \uc554 \ubc1c\uc0dd \uc704\uce58\ub294 \ud3d0, \uce68\uc0d8, \uc720\ubc29, \uac11\uc0c1\uc120, \ub300\uc7a5\uc774\uc5c8\ub2e4.<\/p>\n<p>\ub85c\uc288\ub294 \uc9c0\ub09c 6\uc6d4 \uc77c\ubcf8\uc5d0\uc11c \ub85c\uc990\ub9ac\ud2b8\ub809\uc5d0 \ub300\ud55c \uc2b9\uc778 \ud68d\ub4dd \ub2f9\uc2dc NTRK \uc720\uc804\uc790 \uc591\uc131 \ud658\uc790\ub97c \uc2dd\ubcc4\ud560 \uc9c4\ub2e8 \ud504\ub85c\uadf8\ub7a8(Foundation One CDx)\ub97c \ucd9c\uc2dc \uc608\uc815\uc774\ub77c\uace0 \ubc1d\ud614\ub2e4.<\/p>\n<p>FDA\ub294 \ub85c\uc990\ub9ac\ud2b8\ub809\uc5d0 \ub300\ud574 ROS-1\uc591\uc131 \uc804\uc774\uc131 \ube44\uc18c\uc138\ud3ec\ud3d0\uc554\uc5d0 \ub300\ud574\uc11c\ub3c4 \ud488\ubaa9\ud5c8\uac00\ub97c \uc2b9\uc778\ud588\ub2e4. ROS-1 \uc591\uc131 \ud3d0\uc554\ud658\uc790 51\uba85\uc744 \ub300\uc0c1\uc73c\ub85c ORR\uc740 78%\ub97c \ubcf4\uc600\uc73c\uba70 5.9%\uc758 \ud658\uc790\uc5d0\uc11c \uc885\uc591\uc774 \uc644\uc804 \uc18c\uba78\ub410\ub2e4. \uc57d\ubb3c\uc5d0 \ubc18\uc751\uc744 \ubcf4\uc778 \ud658\uc790 40\uba85 \uc911 55%\uc758 \ud658\uc790\ub294 12\uac1c\uc6d4 \uc774\uc0c1 \uc885\uc591\uc774 \uc904\uc5b4\ub4e0 \uacb0\uacfc\ub97c \ubcf4\uc600\ub2e4.<\/p>\n<p>\ud55c\ud3b8, \ub85c\uc288\ub294 \uad6d\ub0b4\uc5d0\ub3c4 \ub85c\uc990\ub9ac\ud2b8\ub809 \ucd9c\uc2dc\ub97c \uc900\ube44\uc911\uc778 \uac83\uc73c\ub85c \uc54c\ub824\uc84c\ub2e4. \ud55c\uad6d\ub85c\uc288\uc5d0 \ub530\ub974\uba74 2015\ub144\ubd80\ud130 \uc0bc\uc131\uc11c\uc6b8\ubcd1\uc6d0, \uc2e0\ucd0c\uc138\ube0c\ub780\uc2a4 \ubcd1\uc6d0 \ub4f1 6\uac1c\uc758 \uc8fc\uc694 \uc758\ub8cc\uae30\uad00\uc5d0\uc11c 45\uba85\uc758 \ud658\uc790\ub97c \ub300\uc0c1\uc73c\ub85c \uc5d4\ud2b8\ub809\ud2f0\ub2d9(\uc81c\ud488 \ub85c\uc990\ub9ac\ud2b8\ub809) \uc784\uc0c11\/2\uc0c1 \ubc0f \uc784\uc0c13\uc0c1\uc774 \uc9c4\ud589\uc911\uc774\ub2e4. \ub610\ud55c \uc774\ubbf8 \uc2dd\uc57d\ucc98\ub85c\ubd80\ud130 \uc9c0\ub09c 4\uc6d4 ROS-1 \uc591\uc131 \ube44\uc18c\uc138\ud3ec\ud3d0\uc554 \uadf8\ub9ac\uace0 5\uc6d4\uc5d0\ub294 NTRK \uc591\uc131 \uace0\ud615\uc554\uc5d0 \ub300\ud574 \ud76c\uadc0\uc758\uc57d\ud488\uc73c\ub85c \uc9c0\uc815 \ubc1b\uc558\ub2e4.<\/p>\n<\/section>\n<\/div>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>(\uc6d0\ubb38: <a href=\"https:\/\/news.v.daum.net\/v\/20190817070203247\">\uc5ec\uae30<\/a>\ub97c \ud074\ub9ad\ud558\uc138\uc694~)<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; &nbsp; \ud2b9\uc815 \uc885\uc591\uc774 \uc544\ub2cc \ud2b9\uc815 \uc720\uc804\uc790\uc5d0 \ubaa9\ud45c..\ub2e4\uc591\ud55c \uc885\uc591\uc5d0 \uc801\uc6a9\uac00\ub2a5 \uc804\uc774\uc131 \ube44\uc18c\uc138\ud3ec\ud3d0\uc554\uc5d0\ub3c4 \uc2b9\uc778..\uad6d\ub0b4\uc5d0\uc11c\ub3c4 \ud76c\uadc0\uc758\uc57d\ud488 \uc9c0\uc815 &nbsp; &nbsp; &nbsp; \ubbf8\uad6d\uc2dd\ud488\uc758\uc57d\uad6d(FDA)\uc774 \uc554\uc885\uc5d0 \uc0c1\uad00\uc5c6\uc774 \ud2b9\uc815 \uc720\uc804\uc790\ub97c \ubaa9\ud45c\ub85c \ud55c<a href=\"https:\/\/biochemistry.khu.ac.kr\/lab\/?p=4053\" class=\"more-link\">(more&#8230;)<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[33,34,29,30],"tags":[],"class_list":["post-4053","post","type-post","status-publish","format-standard","hentry","category-do-biology","category-lets-do-chemistry","category-lets-do-science","category-recent-science-news"],"aioseo_notices":[],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack-related-posts":[{"id":3602,"url":"https:\/\/biochemistry.khu.ac.kr\/lab\/?p=3602","url_meta":{"origin":4053,"position":0},"title":"1\ud68c \ud22c\uc5ec\uc5d0 25\uc5b5\uc6d0\u2026\uc544\uae30 \uc0b4\ub9ac\ub294 \uc2e0\uc57d, \uc720\uc804\uc790\uce58\ub8cc &#8216;\ud65c\uc9dd&#8217; 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