{"id":10937,"date":"2023-12-05T00:04:00","date_gmt":"2023-12-04T16:04:00","guid":{"rendered":"https:\/\/flcube.com\/?p=10937"},"modified":"2024-11-03T00:06:28","modified_gmt":"2024-11-02T16:06:28","slug":"eli-lillys-jaypirca-receives-fda-accelerated-approval-for-chronic-lymphocytic-leukemia","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=10937","title":{"rendered":"Eli Lilly\u2019s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia"},"content":{"rendered":"\n

The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY<\/a>) an accelerated approval for its reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have received at least two prior lines of therapy. This regulatory milestone follows the FDA’s earlier approval of the drug for mantle cell lymphoma (MCL) earlier this year. The accelerated approval is subject to confirmation from a late-stage trial.<\/p>\n\n\n\n

The preliminary decision was supported by data from a Phase I\/II study, which indicated that in a subgroup of CLL\/SLL patients who had previously received a BTK inhibitor and a BCL-2 inhibitor, the overall response rate (ORR) was 72% and the duration of response (DOR) was 12.2 months.<\/p>\n\n\n\n

As stated in the press release, Jaypirca is the first reversible BTK inhibitor to be introduced in the US, and it is currently involved in several Phase III studies.- Flcube.com<\/a><\/p>\n\n\n\n

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

The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated…<\/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":[16,1852,199,911,80,15],"class_list":["post-10937","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-conditional-approvals","tag-eli-lilly","tag-nyse-lly","tag-priority-reviews","tag-product-approvals"],"yoast_head":"\nEli Lilly\u2019s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated approval for its reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have received at least two prior lines of therapy. This regulatory milestone follows the FDA's earlier approval of the drug for mantle cell lymphoma (MCL) earlier this year. The accelerated approval is subject to confirmation from a late-stage trial.\" \/>\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=10937\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Eli Lilly\u2019s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia\" \/>\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=10937\" \/>\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=\"2023-12-04T16:04:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-02T16:06:28+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=10937#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=10937\"},\"author\":{\"name\":\"Fineline Cube\",\"@id\":\"https:\\\/\\\/flcube.com\\\/#\\\/schema\\\/person\\\/19ad11870d326204db8524d3c3c5e66a\"},\"headline\":\"Eli Lilly\u2019s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia\",\"datePublished\":\"2023-12-04T16:04:00+00:00\",\"dateModified\":\"2024-11-02T16:06:28+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=10937\"},\"wordCount\":171,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"},\"keywords\":[\"Cancer\",\"Conditional approvals\",\"Eli Lilly\",\"NYSE: LLY\",\"Priority reviews\",\"Product approvals\"],\"articleSection\":[\"Company\",\"Drug\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=10937#respond\"]}],\"copyrightYear\":\"2023\",\"copyrightHolder\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#organization\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=10937\",\"url\":\"https:\\\/\\\/flcube.com\\\/?p=10937\",\"name\":\"Eli Lilly\u2019s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia - Insight, China's Pharmaceutical Industry\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/#website\"},\"datePublished\":\"2023-12-04T16:04:00+00:00\",\"dateModified\":\"2024-11-02T16:06:28+00:00\",\"description\":\"The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated approval for its reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have received at least two prior lines of therapy. This regulatory milestone follows the FDA's earlier approval of the drug for mantle cell lymphoma (MCL) earlier this year. The accelerated approval is subject to confirmation from a late-stage trial.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=10937#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/flcube.com\\\/?p=10937\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/flcube.com\\\/?p=10937#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/flcube.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Eli Lilly\u2019s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia\"}]},{\"@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":"Eli Lilly\u2019s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia - Insight, China's Pharmaceutical Industry","description":"The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated approval for its reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have received at least two prior lines of therapy. This regulatory milestone follows the FDA's earlier approval of the drug for mantle cell lymphoma (MCL) earlier this year. The accelerated approval is subject to confirmation from a late-stage trial.","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=10937","og_locale":"en_US","og_type":"article","og_title":"Eli Lilly\u2019s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia","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=10937","og_site_name":"Insight, China's Pharmaceutical Industry","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=61566606313834","article_published_time":"2023-12-04T16:04:00+00:00","article_modified_time":"2024-11-02T16:06:28+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=10937#article","isPartOf":{"@id":"https:\/\/flcube.com\/?p=10937"},"author":{"name":"Fineline Cube","@id":"https:\/\/flcube.com\/#\/schema\/person\/19ad11870d326204db8524d3c3c5e66a"},"headline":"Eli Lilly\u2019s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia","datePublished":"2023-12-04T16:04:00+00:00","dateModified":"2024-11-02T16:06:28+00:00","mainEntityOfPage":{"@id":"https:\/\/flcube.com\/?p=10937"},"wordCount":171,"commentCount":0,"publisher":{"@id":"https:\/\/flcube.com\/#organization"},"keywords":["Cancer","Conditional approvals","Eli Lilly","NYSE: LLY","Priority reviews","Product approvals"],"articleSection":["Company","Drug"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/flcube.com\/?p=10937#respond"]}],"copyrightYear":"2023","copyrightHolder":{"@id":"https:\/\/flcube.com\/#organization"}},{"@type":"WebPage","@id":"https:\/\/flcube.com\/?p=10937","url":"https:\/\/flcube.com\/?p=10937","name":"Eli Lilly\u2019s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia - Insight, China's Pharmaceutical Industry","isPartOf":{"@id":"https:\/\/flcube.com\/#website"},"datePublished":"2023-12-04T16:04:00+00:00","dateModified":"2024-11-02T16:06:28+00:00","description":"The US Food and Drug Administration (FDA) has granted Eli Lilly (NYSE: LLY) an accelerated approval for its reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have received at least two prior lines of therapy. This regulatory milestone follows the FDA's earlier approval of the drug for mantle cell lymphoma (MCL) earlier this year. The accelerated approval is subject to confirmation from a late-stage trial.","breadcrumb":{"@id":"https:\/\/flcube.com\/?p=10937#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/flcube.com\/?p=10937"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/flcube.com\/?p=10937#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/flcube.com\/"},{"@type":"ListItem","position":2,"name":"Eli Lilly\u2019s Jaypirca Receives FDA Accelerated Approval for Chronic Lymphocytic Leukemia"}]},{"@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\/10937","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=10937"}],"version-history":[{"count":1,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/10937\/revisions"}],"predecessor-version":[{"id":10938,"href":"https:\/\/flcube.com\/index.php?rest_route=\/wp\/v2\/posts\/10937\/revisions\/10938"}],"wp:attachment":[{"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=10937"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=10937"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/flcube.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=10937"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}