{"id":654,"date":"2024-08-15T20:57:28","date_gmt":"2024-08-15T12:57:28","guid":{"rendered":"https:\/\/flcube.com\/?p=654"},"modified":"2024-10-13T21:10:59","modified_gmt":"2024-10-13T13:10:59","slug":"astellas-pharma-secures-uk-approval-for-first-in-class-gastric-cancer-therapy-vyloy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=654","title":{"rendered":"Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Astellas Pharma (<a href=\"https:\/\/www.google.com\/finance\/quote\/4503:TYO\">TYO: 4503<\/a>), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">According to a press release from the Medicines and Healthcare products Regulatory Agency (MHRA), the approval allows Vyloy to be used as a first-line treatment in combination with chemotherapy for patients with unresectable or metastatic gastric or gastro-oesophageal junction cancer (GC\/GEJ) who are positive for CLDN18.2 and negative for human epidermal growth factor receptor 2 (HER2).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This approval marks Vyloy\u2019s second significant global market authorization, following its approval in Japan in March 2024. Initially, the U.S. was anticipated to be the first market to grant approval; however, Astellas received a Complete Response Letter from the FDA in January 2024 due to deficiencies in third-party manufacturing. With those issues reportedly resolved, Astellas re-filed in the U.S. in May, and the FDA has set a PDUFA date of November 9, 2024, for its decision on the resubmission.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The UK approval is based on data from two pivotal Phase III trials, GLOW and SUNLIGHT, which assessed zolbetuximab in combination with two distinct chemotherapy regimens, CAPOX and FOLFOX, compared to placebo plus the same regimens. Results indicated that zolbetuximab extended median overall survival by approximately four months relative to the placebo group.- <a href=\"https:\/\/flcube.com\">Flcube.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[353,16,83,25,15,1177],"class_list":["post-654","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-astellas-pharma","tag-cancer","tag-her2","tag-potential-first-in-class","tag-product-approvals","tag-tyo-4503"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=654\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy\" \/>\n<meta property=\"og:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=654\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2024-08-15T12:57:28+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-13T13:10:59+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1894\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Fineline Cube\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=654#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=654\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy\",\"datePublished\":\"2024-08-15T12:57:28+00:00\",\"dateModified\":\"2024-10-13T13:10:59+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=654\"},\"wordCount\":227,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Astellas Pharma\",\"Cancer\",\"HER2\",\"Potential first-in-class\",\"Product approvals\",\"TYO: 4503\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=654#respond\"]}],\"copyrightYear\":\"2024\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=654\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=654\",\"name\":\"Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy - Insight, China&#039;s Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2024-08-15T12:57:28+00:00\",\"dateModified\":\"2024-10-13T13:10:59+00:00\",\"description\":\"Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2).\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=654#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=654\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=654#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"name\":\"Insight, China's Pharmaceutical Industry\",\"description\":\"Fineline Insights, Pharma Clarity\",\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/flcube.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\",\"name\":\"Fineline Infomation and Technology\",\"alternateName\":\"Fineline Info & Tech\",\"url\":\"https:\\\/\\\/flcube.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"contentUrl\":\"https:\\\/\\\/flcube.com\\\/wp-content\\\/uploads\\\/2024\\\/11\\\/Fineline-info-tech-scaled.jpg\",\"width\":2560,\"height\":1894,\"caption\":\"Fineline Infomation and Technology\"},\"image\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=61566606313834\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\",\"name\":\"Fineline Cube\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g\",\"caption\":\"Fineline Cube\"},\"sameAs\":[\"https:\\\/\\\/flcube.com\"],\"url\":\"https:\\\/\\\/flcube.com\\\/?author=1\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy - Insight, China&#039;s Pharmaceutical Industry","description":"Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2).","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:\/\/flcube.com\/?p=654","og_locale":"en_US","og_type":"article","og_title":"Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy","og_description":"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. FLCUBE delivers reliable data, news, and intelligence to broaden your horizons and sharpen your decision-making. Stay informed, stay ahead with FLCUBE.COM","og_url":"https:\/\/flcube.com\/?p=654","og_site_name":"Insight, China&#039;s Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2024-08-15T12:57:28+00:00","article_modified_time":"2024-10-13T13:10:59+00:00","og_image":[{"width":2560,"height":1894,"url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","type":"image\/jpeg"}],"author":"Fineline Cube","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Fineline Cube","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=654#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=654"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy","datePublished":"2024-08-15T12:57:28+00:00","dateModified":"2024-10-13T13:10:59+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=654"},"wordCount":227,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Astellas Pharma","Cancer","HER2","Potential first-in-class","Product approvals","TYO: 4503"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=654#respond"]}],"copyrightYear":"2024","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=654","url":"https:\/\/flcube.com\/?p=654","name":"Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy - Insight, China&#039;s Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2024-08-15T12:57:28+00:00","dateModified":"2024-10-13T13:10:59+00:00","description":"Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2).","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=654#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=654"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=654#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy"}]},{"@type":"WebSite","@id":"https:\/\/flcube.com\/#website","url":"https:\/\/flcube.com\/","name":"Insight, China's Pharmaceutical Industry","description":"Fineline Insights, Pharma Clarity","publisher":{"@id":"https:\/\/flcube.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/flcube.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/flcube.com\/#organization","name":"Fineline Infomation and Technology","alternateName":"Fineline Info & Tech","url":"https:\/\/flcube.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/","url":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","contentUrl":"https:\/\/flcube.com\/wp-content\/uploads\/2024\/11\/Fineline-info-tech-scaled.jpg","width":2560,"height":1894,"caption":"Fineline Infomation and Technology"},"image":{"@id":"https:\/\/flcube.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=61566606313834"]},{"@type":"Person","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a","name":"Fineline Cube","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/89f733aaed3d2d91d7d6f45d0e9ab509e3004e8243c6e57620b36380684657f2?s=96&d=mm&r=g","caption":"Fineline Cube"},"sameAs":["https:\/\/flcube.com"],"url":"https:\/\/flcube.com\/?author=1"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/654","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=654"}],"version-history":[{"count":3,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/654\/revisions"}],"predecessor-version":[{"id":6174,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/654\/revisions\/6174"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=654"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=654"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=654"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}