{"id":612,"date":"2024-08-19T20:18:23","date_gmt":"2024-08-19T12:18:23","guid":{"rendered":"https:\/\/flcube.com\/?p=612"},"modified":"2024-10-13T18:44:52","modified_gmt":"2024-10-13T10:44:52","slug":"astrazenecas-imfinzi-gains-fda-approval-for-neoadjuvant-use-in-early-stage-lung-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=612","title":{"rendered":"AstraZeneca’s Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer"},"content":{"rendered":"\n

AstraZeneca (NASDAQ: AZN<\/a>, LON: AZN<\/a>) , the UK-based pharmaceutical powerhouse, has secured US FDA approval for a new indication of its PD-L1 inhibitor, Imfinzi (durvalumab). The FDA has authorized the use of Imfinzi in combination with chemotherapy for adults with resectable early-stage non-small cell lung cancer (NSCLC) classified as IIA-IIIB, specifically for patients without EGFR or ALK mutations.<\/p>\n\n\n\n

The treatment protocol involves administering Imfinzi alongside chemotherapy prior to surgery (neoadjuvant setting), followed by Imfinzi as a monotherapy post-surgery (adjuvant therapy).<\/p>\n\n\n\n

This approval is based on the pivotal AEGEAN clinical trial, which demonstrated a 32% reduction in the risk of cancer recurrence, progression, or death when compared to neoadjuvant chemotherapy alone (CI 0.53-0.88; p=0.003902). The trial also revealed a significant improvement in pathologic complete response (pCR), with a rate of 17.2% for the combination therapy versus 4.3% for chemotherapy alone.<\/p>\n\n\n\n

Imfinzi is already approved in the UK, Switzerland, and Taiwan for the early-stage NSCLC indication highlighted in the AEGEAN trial. Initially approved in 2017 for bladder cancer, Imfinzi has garnered eight indication approvals from the US FDA to date. The drug has proven to be a commercial success, generating over USD 1 billion in quarterly sales, with Q2 2024 sales reported at USD 1.147 billion, reflecting an 18% year-on-year growth.<\/p>\n\n\n\n

Additionally, Imfinzi recently received both priority review and breakthrough therapy designation for its potential use in treating limited-stage small-cell lung cancer (LS-SCLC), with a PDUFA date set for Q4 2024.- Flcube.com<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

AstraZeneca (NASDAQ: AZN, LON: AZN) , the UK-based pharmaceutical powerhouse, has secured US FDA approval…<\/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_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}},"categories":[7,11],"tags":[130,770,896,871],"class_list":["post-612","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-astrazeneca","tag-az","tag-lon-azn","tag-nasdaq-azn"],"yoast_head":"\nAstraZeneca's Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"AstraZeneca (NASDAQ: AZN, LON: AZN) , the UK-based pharmaceutical powerhouse, has secured US FDA approval for a new indication of its PD-L1 inhibitor, Imfinzi (durvalumab). The FDA has authorized the use of Imfinzi in combination with chemotherapy for adults with resectable early-stage non-small cell lung cancer (NSCLC) classified as IIA-IIIB, specifically for patients without EGFR or ALK mutations.\" \/>\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=612\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AstraZeneca's Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer\" \/>\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=612\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China's Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2024-08-19T12:18:23+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-13T10:44:52+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=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=612#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=612\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"AstraZeneca’s Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer\",\"datePublished\":\"2024-08-19T12:18:23+00:00\",\"dateModified\":\"2024-10-13T10:44:52+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=612\"},\"wordCount\":245,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"AstraZeneca\",\"AZ\",\"LON: AZN\",\"NASDAQ: AZN\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=612#respond\"]}],\"copyrightYear\":\"2024\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=612\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=612\",\"name\":\"AstraZeneca's Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2024-08-19T12:18:23+00:00\",\"dateModified\":\"2024-10-13T10:44:52+00:00\",\"description\":\"AstraZeneca (NASDAQ: AZN, LON: AZN) , the UK-based pharmaceutical powerhouse, has secured US FDA approval for a new indication of its PD-L1 inhibitor, Imfinzi (durvalumab). The FDA has authorized the use of Imfinzi in combination with chemotherapy for adults with resectable early-stage non-small cell lung cancer (NSCLC) classified as IIA-IIIB, specifically for patients without EGFR or ALK mutations.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=612#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=612\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=612#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"AstraZeneca’s Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer\"}]},{\"@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":"AstraZeneca's Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer - Insight, China's Pharmaceutical Industry","description":"AstraZeneca (NASDAQ: AZN, LON: AZN) , the UK-based pharmaceutical powerhouse, has secured US FDA approval for a new indication of its PD-L1 inhibitor, Imfinzi (durvalumab). The FDA has authorized the use of Imfinzi in combination with chemotherapy for adults with resectable early-stage non-small cell lung cancer (NSCLC) classified as IIA-IIIB, specifically for patients without EGFR or ALK mutations.","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=612","og_locale":"en_US","og_type":"article","og_title":"AstraZeneca's Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer","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=612","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2024-08-19T12:18:23+00:00","article_modified_time":"2024-10-13T10:44:52+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":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/flcube.com\/?p=612#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=612"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"AstraZeneca’s Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer","datePublished":"2024-08-19T12:18:23+00:00","dateModified":"2024-10-13T10:44:52+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=612"},"wordCount":245,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["AstraZeneca","AZ","LON: AZN","NASDAQ: AZN"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=612#respond"]}],"copyrightYear":"2024","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=612","url":"https:\/\/flcube.com\/?p=612","name":"AstraZeneca's Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2024-08-19T12:18:23+00:00","dateModified":"2024-10-13T10:44:52+00:00","description":"AstraZeneca (NASDAQ: AZN, LON: AZN) , the UK-based pharmaceutical powerhouse, has secured US FDA approval for a new indication of its PD-L1 inhibitor, Imfinzi (durvalumab). The FDA has authorized the use of Imfinzi in combination with chemotherapy for adults with resectable early-stage non-small cell lung cancer (NSCLC) classified as IIA-IIIB, specifically for patients without EGFR or ALK mutations.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=612#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=612"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=612#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"AstraZeneca’s Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer"}]},{"@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\/612","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=612"}],"version-history":[{"count":4,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/612\/revisions"}],"predecessor-version":[{"id":5983,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/612\/revisions\/5983"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=612"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=612"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=612"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}