{"id":30530,"date":"2026-03-27T10:44:58","date_gmt":"2026-03-27T10:44:58","guid":{"rendered":"https:\/\/itbusinesstoday.com\/?p=30530"},"modified":"2026-03-27T10:44:58","modified_gmt":"2026-03-27T10:44:58","slug":"taletrectinib-moves-toward-europe-approval-review","status":"publish","type":"post","link":"https:\/\/itbusinesstoday.com\/ja\/health-tech\/pharma\/taletrectinib-moves-toward-europe-approval-review\/","title":{"rendered":"\u30bf\u30ec\u30c8\u30ec\u30af\u30c1\u30cb\u30d6\u3001\u6b27\u5dde\u3067\u306e\u627f\u8a8d\u5be9\u67fb\u306b\u5411\u3051\u3066\u524d\u9032"},"content":{"rendered":"<p>\u30a8\u30fc\u30b6\u30a4\u682a\u5f0f\u4f1a\u793e\u3068Nuvation Bio Inc.\u306f\u3001taletrectinib\u3092\u6b27\u5dde\u3067\u6b21\u306e\u30b9\u30c6\u30fc\u30b8\u306b\u9032\u3081\u307e\u3057\u305f\u3002\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08European Medicines Agency\uff09\u306f\u672c\u7533\u8acb\u3092\u627f\u8a8d\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u306f\u57fa\u672c\u7684\u306b\u3001\u7533\u8acb\u66f8\u985e\u304c\u5b8c\u6210\u3057\u305f\u3053\u3068\u3092\u610f\u5473\u3057\u3001\u4eca\u5f8c\u306f\u6a19\u6e96\u7684\u306a\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3067\u672c\u5be9\u67fb\u306b\u79fb\u884c\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002.<\/p>\n<p>\u672c\u85ac\u306f\u3001\u521d\u3081\u3066\u627f\u8a8d\u3055\u308c\u305f\u65b0\u85ac\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30bf\u30ec\u30c8\u30ec\u30af\u30c1\u30cb\u30d6\u306f\u9032\u884c\u6027ROS1\u967d\u6027\u975e\u5c0f\u7d30\u80de\u80ba\u304c\u3093\u306e\u9069\u5fdc\u3067\u7c73\u56fd\u3001\u4e2d\u56fd\u3001\u65e5\u672c\u3067\u3059\u3067\u306b\u627f\u8a8d\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u7c73\u56fd\u3068\u65e5\u672c\u3067\u306fIBTROZI\u3068\u3057\u3066\u8ca9\u58f2\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u4e2d\u56fd\u3067\u306fDOVBLERON\u3068\u3057\u3066\u8ca9\u58f2\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3064\u307e\u308a\u3001\u4e0b\u5730\u306f\u3059\u3067\u306b\u3042\u308b\u306e\u3067\u3059\u3002\u6b21\u306e\u30b9\u30c6\u30c3\u30d7\u306f\u30e8\u30fc\u30ed\u30c3\u30d1\u3067\u3059\u3002.<\/p>\n<p>\u3053\u306e\u85ac\u5264\u306f\u7279\u5b9a\u306e\u5909\u7570\u3092\u6a19\u7684\u3068\u3057\u307e\u3059\u3002ROS1\u967d\u6027\u306e\u75c7\u4f8b\u306f\u975e\u5c0f\u7d30\u80de\u80ba\u304c\u3093\u306e\u7d042\u30d1\u30fc\u30bb\u30f3\u30c8\u3067\u3059\u3002\u30e8\u30fc\u30ed\u30c3\u30d1\u306e\u80ba\u764c\u306e\u6d41\u884c\u306f\u3001\u305d\u306e\u5b9f\u969b\u306e\u898f\u6a21\u304c\u660e\u3089\u304b\u306b\u306a\u308b\u307e\u3067\u306f\u5c0f\u3055\u306a\u554f\u984c\u306b\u898b\u3048\u307e\u3059\u3002\u5e74\u9593\u8a3a\u65ad\u7387\u306f400,000\u4f8b\u306b\u9054\u3057\u3001\u975e\u5c0f\u7d30\u80de\u80ba\u304c\u3093\u304c\u305d\u306e\u307b\u3068\u3093\u3069\u3092\u5360\u3081\u3066\u3044\u307e\u3059\u3002\u3064\u307e\u308a\u3001\u30cb\u30c3\u30c1\u306a\u30bb\u30b0\u30e1\u30f3\u30c8\u3067\u3042\u3063\u3066\u3082\u3001\u307e\u3060\u610f\u5473\u304c\u3042\u308b\u306e\u3067\u3059\u3002.<\/p>\n<h4>\u3053\u3061\u3089\u3082\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\uff1a <a class=\"p-url\" href=\"https:\/\/itbusinesstoday.com\/ja\/health-tech\/pharma\/transcosmos-partners-tokyo-university-on-pharmacist-gap\/\" rel=\"bookmark\">\u30c8\u30e9\u30f3\u30b9\u30b3\u30b9\u30e2\u30b9\u3001\u85ac\u5264\u5e2b\u683c\u5dee\u554f\u984c\u3067\u6771\u4eac\u5927\u5b66\u3068\u63d0\u643a<\/a><\/h4>\n<p>\u672c\u7533\u8acb\u306e\u80cc\u666f\u306b\u3042\u308b\u30c7\u30fc\u30bf\u306f\u3001TRUST-I\u304a\u3088\u3073TRUST-II\u8a66\u9a13\u306b\u3088\u308b\u3082\u306e\u3067\u3059\u3002TRUST-I\u304a\u3088\u3073TRUST-II\u8a66\u9a13\u306f\u3001\u4e16\u754c\u7684\u306a\u60a3\u8005\u7fa4\u3067\u5b9f\u65bd\u3055\u308c\u305f\u7b2c2\u76f8\u8a66\u9a13\u3067\u3059\u3002\u7d50\u679c\u306f\u3059\u3067\u306b\u767a\u8868\u3055\u308c\u3066\u304a\u308a\u3001\u3088\u308a\u9577\u671f\u9593\u306e\u8ffd\u8de1\u8abf\u67fb\u306b\u3088\u308b\u6700\u65b0\u30c7\u30fc\u30bf\u304c\u307e\u3082\u306a\u304f\u767a\u8868\u3055\u308c\u308b\u4e88\u5b9a\u3067\u3059\u3002\u898f\u5236\u5f53\u5c40\u304c\u91cd\u8996\u3059\u308b\u306e\u306f\u3001\u521d\u671f\u306e\u53cd\u5fdc\u3060\u3051\u3067\u306a\u304f\u3001\u9577\u671f\u306b\u308f\u305f\u308b\u4e00\u8cab\u6027\u3060\u304b\u3089\u3067\u3059\u3002.<\/p>\n<p>\u3053\u306e\u4e0b\u306b\u306f\u30d3\u30b8\u30cd\u30b9\u7684\u306a\u5074\u9762\u3082\u3042\u308a\u307e\u3059\u30022026\u5e74\u521d\u3081\u306b, <a href=\"https:\/\/www.eisai.com\/\">\u30a8\u30fc\u30b6\u30a4<\/a> \u305d\u3057\u3066 <a href=\"https:\/\/nuvationbio.com\/\">\u30cc\u30d9\u30fc\u30b7\u30e7\u30f3<\/a> \u30bf\u30ec\u30c8\u30ec\u30af\u30c1\u30cb\u30d6\u3092\u7c73\u56fd\u3001\u4e2d\u56fd\u3001\u65e5\u672c\u4ee5\u5916\u306e\u8907\u6570\u306e\u5730\u57df\u3067\u4f7f\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u305f\u3081\u3067\u3059\u3002\u6b27\u5dde\u306f\u307e\u3055\u306b\u305d\u306e\u8a08\u753b\u306b\u8a72\u5f53\u3057\u307e\u3059\u3002\u3053\u306e\u5f8c\u3001\u82f1\u56fd\u3001\u30ab\u30ca\u30c0\u3001\u304a\u3088\u3073\u30a8\u30fc\u30b6\u30a4\u306e\u30e9\u30a4\u30bb\u30f3\u30b9\u5730\u57df\u5185\u306e\u4ed6\u306e\u5e02\u5834\u306b\u3082\u7533\u8acb\u3059\u308b\u4e88\u5b9a\u3067\u3059\u3002.<\/p>\n<p>\u3067\u3059\u304b\u3089\u3001\u3053\u308c\u306f\u5358\u306a\u308b1\u56de\u306e\u627f\u8a8d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3088\u308a\u5e83\u7bc4\u306a\u5c55\u958b\u306e\u4e00\u90e8\u306a\u306e\u3067\u3059\u3002\u3053\u306e\u85ac\u306f\u3059\u3067\u306b\u4e3b\u8981\u306a\u5e02\u5834\u3067\u6d41\u901a\u3057\u3066\u3044\u307e\u3059\u3002\u4eca\u306f\u3001\u6b8b\u308a\u306e\u5927\u304d\u306a\u5730\u57df\u3067\u627f\u8a8d\u3092\u53d6\u5f97\u3057\u3001\u4e00\u6b69\u4e00\u6b69\u3088\u308a\u5e83\u3044\u30d7\u30ec\u30bc\u30f3\u30b9\u3092\u7bc9\u3044\u3066\u3044\u304f\u3053\u3068\u3067\u3059\u3002.<\/p>","protected":false},"excerpt":{"rendered":"<p>Eisai Co., Ltd. and Nuvation Bio Inc. have pushed taletrectinib into the next stage in Europe. The European Medicines Agency has validated the application. That basically means the file is complete and now it moves into a full review under the standard timeline. This is not a fresh drug entering the system for the first time. Taletrectinib is already approved in the U.S., China, and Japan for advanced ROS1-positive non-small cell lung cancer. In the U.S. and Japan, it is sold as IBTROZI. In China, it is marketed as DOVBLERON. So the groundwork is already there. Europe is the next obvious step. The drug targets a specific mutation. ROS1-positive cases [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":30531,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"wprm-recipe-roundup-name":"","wprm-recipe-roundup-description":"","postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""},"footnotes":""},"categories":[89,207,237,182],"tags":[1715,12176,424,12174,12175],"ppma_author":[572],"class_list":{"0":"post-30530","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health-tech","8":"category-international","9":"category-news","10":"category-pharma","11":"tag-eisai","12":"tag-nuvation-bio","13":"tag-pharma","14":"tag-ros1-positive","15":"tag-taletrectinib"},"yoast_head":"<!-- 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