{"id":22524,"date":"2023-01-28T22:25:00","date_gmt":"2023-01-28T14:25:00","guid":{"rendered":"https:\/\/flcube.com\/?p=22524"},"modified":"2025-01-21T22:27:24","modified_gmt":"2025-01-21T14:27:24","slug":"novartis-kisqali-receives-nmpa-approval-for-premenopausal-breast-cancer","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=22524","title":{"rendered":"Novartis’ Kisqali Receives NMPA Approval for Premenopausal Breast Cancer"},"content":{"rendered":"\n

Swiss pharmaceutical giant Novartis (NYSE: NVS<\/a>) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Kisqali (ribociclib), a cyclin-dependent kinase (CDK) 4\/6 inhibitor. The drug is now approved for use as initial endocrine therapy in premenopausal or perimenopausal female patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor and a luteinizing hormone-releasing hormone (LHRH) agonist. Kisqali is the only CDK4\/6 inhibitor approved for this indication in China.<\/p>\n\n\n\n

Global Approval and Clinical Data<\/strong>
Ribociclib was first approved in the US in March 2017 for first-line treatment of postmenopausal women with HR+\/HER2- advanced or metastatic breast cancer, followed by EU approval five months later. Novartis filed for approval in China in October 2021. The drug is currently available in 95 countries worldwide and is the only CDK4\/6 inhibitor to demonstrate clear, statistically significant overall survival benefits in HR+\/HER2- locally advanced or metastatic breast cancer.<\/p>\n\n\n\n

MONALEESA Study Results<\/strong>
The MONALEESA global study includes three trials filed by Novartis. The MONALEESA-7 study results showed that ribociclib combined with endocrine therapy produced statistically significant benefits in progression-free survival (PFS) and overall survival (OS) compared to endocrine therapy alone in premenopausal patients with HR+\/HER2- advanced breast cancer. The NMPA approval is based on a China-specific study, which demonstrated PFS benefits and good safety characteristics for ribociclib compared to placebo, regardless of menopausal status. The overall safety profile was consistent with known adverse reactions and aligned with the global MONALEESA study results.<\/a>-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval from the National Medical…<\/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":[16,140,865,15],"class_list":["post-22524","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-novartis","tag-nyse-nvs","tag-product-approvals"],"yoast_head":"\nNovartis' Kisqali Receives NMPA Approval for Premenopausal Breast Cancer - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Kisqali (ribociclib), a cyclin-dependent kinase (CDK) 4\/6 inhibitor. The drug is now approved for use as initial endocrine therapy in premenopausal or perimenopausal female patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor and a luteinizing hormone-releasing hormone (LHRH) agonist. Kisqali is the only CDK4\/6 inhibitor approved for this indication in China.\" \/>\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=22524\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Novartis' Kisqali Receives NMPA Approval for Premenopausal Breast 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=22524\" \/>\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=\"2023-01-28T14:25:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-01-21T14:27:24+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=22524#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22524\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Novartis’ Kisqali Receives NMPA Approval for Premenopausal Breast Cancer\",\"datePublished\":\"2023-01-28T14:25:00+00:00\",\"dateModified\":\"2025-01-21T14:27:24+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22524\"},\"wordCount\":271,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Cancer\",\"Novartis\",\"NYSE: NVS\",\"Product approvals\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=22524#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22524\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=22524\",\"name\":\"Novartis' Kisqali Receives NMPA Approval for Premenopausal Breast Cancer - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-01-28T14:25:00+00:00\",\"dateModified\":\"2025-01-21T14:27:24+00:00\",\"description\":\"Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Kisqali (ribociclib), a cyclin-dependent kinase (CDK) 4\\\/6 inhibitor. The drug is now approved for use as initial endocrine therapy in premenopausal or perimenopausal female patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor and a luteinizing hormone-releasing hormone (LHRH) agonist. Kisqali is the only CDK4\\\/6 inhibitor approved for this indication in China.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22524#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=22524\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=22524#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Novartis’ Kisqali Receives NMPA Approval for Premenopausal Breast 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":"Novartis' Kisqali Receives NMPA Approval for Premenopausal Breast Cancer - Insight, China's Pharmaceutical Industry","description":"Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Kisqali (ribociclib), a cyclin-dependent kinase (CDK) 4\/6 inhibitor. The drug is now approved for use as initial endocrine therapy in premenopausal or perimenopausal female patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor and a luteinizing hormone-releasing hormone (LHRH) agonist. Kisqali is the only CDK4\/6 inhibitor approved for this indication in China.","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=22524","og_locale":"en_US","og_type":"article","og_title":"Novartis' Kisqali Receives NMPA Approval for Premenopausal Breast 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=22524","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-01-28T14:25:00+00:00","article_modified_time":"2025-01-21T14:27:24+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=22524#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=22524"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Novartis’ Kisqali Receives NMPA Approval for Premenopausal Breast Cancer","datePublished":"2023-01-28T14:25:00+00:00","dateModified":"2025-01-21T14:27:24+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=22524"},"wordCount":271,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Cancer","Novartis","NYSE: NVS","Product approvals"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=22524#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=22524","url":"https:\/\/flcube.com\/?p=22524","name":"Novartis' Kisqali Receives NMPA Approval for Premenopausal Breast Cancer - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-01-28T14:25:00+00:00","dateModified":"2025-01-21T14:27:24+00:00","description":"Swiss pharmaceutical giant Novartis (NYSE: NVS) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Kisqali (ribociclib), a cyclin-dependent kinase (CDK) 4\/6 inhibitor. The drug is now approved for use as initial endocrine therapy in premenopausal or perimenopausal female patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer, in combination with an aromatase inhibitor and a luteinizing hormone-releasing hormone (LHRH) agonist. Kisqali is the only CDK4\/6 inhibitor approved for this indication in China.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=22524#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=22524"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=22524#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Novartis’ Kisqali Receives NMPA Approval for Premenopausal Breast 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\/22524","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=22524"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/22524\/revisions"}],"predecessor-version":[{"id":22525,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/22524\/revisions\/22525"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=22524"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22524"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22524"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}