\u30b0\u30ed\u30fc\u30d6\u30cb\u30e5\u30fc\u30b9\u30ef\u30a4\u30e4\u30fc<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"Kura Oncology, Inc., and Kyowa Kirin Co., Ltd. announced Kura submitted a New Drug Application (NDA) for ziftomenib, a highly selective, once-daily, oral, investigational menin inhibitor, for the treatment of adult patients with relapsed or refractory (R\/R) acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM 1) mutation to the U.S. Food and Drug Administration (FDA) on March 31, 2025. Ziftomenib has received Breakthrough Therapy, Fast Track, and Orphan Drug Designations. The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review; Kura expects to receive notification from the FDA on this preliminary evaluation in the second quarter of 2025. Priority Review […]<\/p>\n","protected":false},"author":4,"featured_media":9128,"comment_status":"closed","ping_status":"open","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":[3006,3004,3005,3002,424,3003],"ppma_author":[205],"class_list":{"0":"post-9042","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-acute-myeloid-leukemia","12":"tag-kura-oncology","13":"tag-kyowa-kiri","14":"tag-nucleophosmin-1","15":"tag-pharma","16":"tag-ziftomenib"},"yoast_head":"\n
Kura Oncology, Kyowa Kirin Submit Ziftomenib to FDA<\/title>\n<meta name=\"description\" content=\"Kura Oncology has submitted an NDA to the FDA for ziftomenib, an investigational oral treatment for adults with relapsed or with NPM1 mutation\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/itbusinesstoday.com\/ja\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kura Oncology, Kyowa Kirin Submit Ziftomenib to FDA\" \/>\n<meta property=\"og:description\" content=\"Kura Oncology has submitted an NDA to the FDA for ziftomenib, an investigational oral treatment for adults with relapsed or with NPM1 mutation\" \/>\n<meta property=\"og:url\" content=\"https:\/\/itbusinesstoday.com\/ja\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/\" \/>\n<meta property=\"og:site_name\" content=\"itbusinesstoday\" \/>\n<meta property=\"article:published_time\" content=\"2025-04-09T11:23:07+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-05-06T07:54:03+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/04\/Kura-Oncology-and-Kyowa-Kirin-Announce-Submission-of-New-Drug-Application-for-Ziftomenib-to-FDA.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"800\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"NewsDesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"NewsDesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"2\u5206\" \/>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"\u30af\u30e9\u30fb\u30aa\u30f3\u30b3\u30ed\u30b8\u30fc\u3068\u5354\u548c\u30ad\u30ea\u30f3\u3001\u30b8\u30d5\u30c8\u30e1\u30cb\u30d6\u3092FDA\u306b\u7533\u8acb","description":"Kura Oncology \u793e\u306f\u3001\u518d\u767a\u307e\u305f\u306f NPM1 \u907a\u4f1d\u5b50\u5909\u7570\u3092\u6709\u3059\u308b\u6210\u4eba\u306e\u7d4c\u53e3\u6cbb\u7642\u85ac ziftomenib \u306e\u65b0\u85ac\u627f\u8a8d\u7533\u8acb\u3092 FDA \u306b\u63d0\u51fa\u3057\u307e\u3057\u305f\u3002","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/itbusinesstoday.com\/ja\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/","og_locale":"ja_JP","og_type":"article","og_title":"Kura Oncology, Kyowa Kirin Submit Ziftomenib to FDA","og_description":"Kura Oncology has submitted an NDA to the FDA for ziftomenib, an investigational oral treatment for adults with relapsed or with NPM1 mutation","og_url":"https:\/\/itbusinesstoday.com\/ja\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/","og_site_name":"itbusinesstoday","article_published_time":"2025-04-09T11:23:07+00:00","article_modified_time":"2025-05-06T07:54:03+00:00","og_image":[{"width":1200,"height":800,"url":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/04\/Kura-Oncology-and-Kyowa-Kirin-Announce-Submission-of-New-Drug-Application-for-Ziftomenib-to-FDA.webp","type":"image\/webp"}],"author":"NewsDesk","twitter_card":"summary_large_image","twitter_misc":{"\u57f7\u7b46\u8005":"NewsDesk","\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593":"2\u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/itbusinesstoday.com\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/#article","isPartOf":{"@id":"https:\/\/itbusinesstoday.com\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/"},"author":{"name":"NewsDesk","@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#\/schema\/person\/d58d81f55e8acd257ab63d49fb4ea812"},"headline":"Kura Oncology, Kyowa Kirin Submit its Ziftomenib to FDA","datePublished":"2025-04-09T11:23:07+00:00","dateModified":"2025-05-06T07:54:03+00:00","mainEntityOfPage":{"@id":"https:\/\/itbusinesstoday.com\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/"},"wordCount":303,"publisher":{"@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#organization"},"image":{"@id":"https:\/\/itbusinesstoday.com\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/#primaryimage"},"thumbnailUrl":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/04\/Kura-Oncology-and-Kyowa-Kirin-Announce-Submission-of-New-Drug-Application-for-Ziftomenib-to-FDA.webp","keywords":["acute myeloid leukemia","Kura Oncology","Kyowa Kiri","nucleophosmin 1","Pharma","Ziftomenib"],"articleSection":["Health Tech","International","News","Pharma"],"inLanguage":"ja"},{"@type":"WebPage","@id":"https:\/\/itbusinesstoday.com\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/","url":"https:\/\/itbusinesstoday.com\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/","name":"\u30af\u30e9\u30fb\u30aa\u30f3\u30b3\u30ed\u30b8\u30fc\u3068\u5354\u548c\u30ad\u30ea\u30f3\u3001\u30b8\u30d5\u30c8\u30e1\u30cb\u30d6\u3092FDA\u306b\u7533\u8acb","isPartOf":{"@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#website"},"primaryImageOfPage":{"@id":"https:\/\/itbusinesstoday.com\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/#primaryimage"},"image":{"@id":"https:\/\/itbusinesstoday.com\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/#primaryimage"},"thumbnailUrl":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/04\/Kura-Oncology-and-Kyowa-Kirin-Announce-Submission-of-New-Drug-Application-for-Ziftomenib-to-FDA.webp","datePublished":"2025-04-09T11:23:07+00:00","dateModified":"2025-05-06T07:54:03+00:00","description":"Kura Oncology \u793e\u306f\u3001\u518d\u767a\u307e\u305f\u306f NPM1 \u907a\u4f1d\u5b50\u5909\u7570\u3092\u6709\u3059\u308b\u6210\u4eba\u306e\u7d4c\u53e3\u6cbb\u7642\u85ac ziftomenib \u306e\u65b0\u85ac\u627f\u8a8d\u7533\u8acb\u3092 FDA \u306b\u63d0\u51fa\u3057\u307e\u3057\u305f\u3002","breadcrumb":{"@id":"https:\/\/itbusinesstoday.com\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/#breadcrumb"},"inLanguage":"ja","potentialAction":[{"@type":"ReadAction","target":["https:\/\/itbusinesstoday.com\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/"]}]},{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/itbusinesstoday.com\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/#primaryimage","url":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/04\/Kura-Oncology-and-Kyowa-Kirin-Announce-Submission-of-New-Drug-Application-for-Ziftomenib-to-FDA.webp","contentUrl":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/04\/Kura-Oncology-and-Kyowa-Kirin-Announce-Submission-of-New-Drug-Application-for-Ziftomenib-to-FDA.webp","width":1200,"height":800,"caption":"Kura-Oncology"},{"@type":"BreadcrumbList","@id":"https:\/\/itbusinesstoday.com\/health-tech\/kura-oncology-kyowa-kirin-submit-its-ziftomenib-to-fda\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/itbusinesstoday.com\/"},{"@type":"ListItem","position":2,"name":"Kura Oncology, Kyowa Kirin Submit its Ziftomenib to FDA"}]},{"@type":"WebSite","@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#website","url":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/","name":"\u30a4\u30c3\u30c8\u30d3\u30b8\u30cd\u30b9\u30c8\u30a5\u30c7\u30a4","description":"","publisher":{"@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"ja"},{"@type":"Organization","@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#organization","name":"\u30a4\u30c3\u30c8\u30d3\u30b8\u30cd\u30b9\u30c8\u30a5\u30c7\u30a4","url":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/","logo":{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#\/schema\/logo\/image\/","url":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/Asset-1.png","contentUrl":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/Asset-1.png","width":663,"height":275,"caption":"itbusinesstoday"},"image":{"@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#\/schema\/person\/d58d81f55e8acd257ab63d49fb4ea812","name":"\u30cb\u30e5\u30fc\u30b9\u30c7\u30b9\u30af","image":{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/it.png74f313ad3d6fa27a1eee85c30be63d03","url":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/it.png","contentUrl":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/it.png","caption":"NewsDesk"},"sameAs":["https:\/\/itbusinesstoday.com"],"url":"https:\/\/itbusinesstoday.com\/ja\/author\/newsdesk\/"}]}},"authors":[{"term_id":205,"user_id":4,"is_guest":0,"slug":"newsdesk","display_name":"NewsDesk","avatar_url":{"url":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/it.png","url2x":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/it.png"},"0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/posts\/9042","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/comments?post=9042"}],"version-history":[{"count":2,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/posts\/9042\/revisions"}],"predecessor-version":[{"id":10784,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/posts\/9042\/revisions\/10784"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/media\/9128"}],"wp:attachment":[{"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/media?parent=9042"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/categories?post=9042"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/tags?post=9042"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/ppma_author?post=9042"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}