{"id":3781,"date":"2026-09-23T21:59:48","date_gmt":"2026-09-23T21:59:48","guid":{"rendered":"https:\/\/drsoniafawad.com\/?p=3781"},"modified":"2026-09-23T21:59:48","modified_gmt":"2026-09-23T21:59:48","slug":"fda-oks-lyrfigtu-for-previously-treated-bile-duct-cancer","status":"publish","type":"post","link":"https:\/\/drsoniafawad.com\/?p=3781","title":{"rendered":"FDA OKs Lyrfigtu for previously treated bile duct cancer"},"content":{"rendered":"<p><br \/>\n<\/p>\n<div data-component=\"ArticleContent\">\n<div class=\"article__below-title\">\n<div class=\" article__posted-date\">\n<p>September 23, 2026<\/p>\n<p>1 min read<\/p>\n<\/p><\/div>\n<div class=\"mobile-trust-box\">\n<div class=\"row\">\n<div class=\"col-12 col-md-5 d-xl-none\">\n<div class=\"trust-box\">\n<div class=\"trust-box-logo d-none d-md-block\">\n            <img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/hot.svg?la=en&amp;h=24&amp;w=141&amp;hash=2F86D471C8514C0E334E329AA799E8B4\" class=\"logo-img\" height=\"24\" alt=\"hemonc today logo\" width=\"141\"\/>\n          <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"col-12 col-md-6 offset-md-1 offset-xl-0 col-xl-12\">\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse u110bc190ccb54f9badeb3b345069fd57\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. Please try again later. If you continue to have this issue please contact <a href=\"https:\/\/www.healio.com\/news\/hematology-oncology\/20260923\/mailto:customerservice@slackinc.com\">customerservice@slackinc.com<\/a>.<\/strong>  <\/p>\n<p><button data-dismiss=\"modal\" class=\"btn btn-primary btn-lg btn-block\">Back to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<h2>Key takeaways:<\/h2>\n<ul>\n<li>FDA approved Lyrfigtu for previously treated FGFR2-mutated unresectable, locally advanced or metastatic cholangiocarcinoma.<\/li>\n<li>REFOCUS trial data showed a 46% ORR and an 11.8-month median duration of response.<\/li>\n<\/ul>\n<p>The FDA approved lirafugratinib \u2014 a kinase inhibitor \u2014 for adults with previously treated unresectable, <a rel=\"noopener noreferrer\" href=\"https:\/\/www.healio.com\/news\/hematology-oncology\/20260508\/fda-approves-bizengri-as-first-treatment-for-adults-with-rare-bile-duct-cancer\" id=\"rId10\" target=\"_blank\">locally advanced or metastatic cholangiocarcinoma<\/a>.<\/p>\n<p>The indication for lirafugratinib (Lyrfigtu, Elevar Therapeutics) applies to patients with a fibroblast growth factor receptor 2 (<i>FGFR2) <\/i>gene fusion or other rearrangement.<\/p>\n<figure class=\"figure article__og-image\">&#13;\n    <picture>&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=476\" media=\"(max-width: 768px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=800\" media=\"(max-width: 992px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=595\" media=\"(max-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=476\" media=\"(min-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.webp?w=476\">&#13;<br \/>\n&#13;<br \/>\n      <img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/slack-news\/generic-infographics\/2023\/generic-fda-news.jpg?w=800\" alt=\"Generic FDA News infographic\" class=\"figure-img img-fluid\" width=\"800\"\/>&#13;<br \/>\n    <\/source><\/source><\/source><\/source><\/source><\/picture>&#13;<figcaption class=\"figure-caption\">&#13;<\/p>\n<p class=\"Body\">The FDA approved lirafugratinib \u2014 a kinase inhibitor \u2014 for adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma.<\/p>\n<p>&#13;<br \/>\n    <\/figcaption>&#13;<br \/>\n  <\/figure>\n<p>The FDA based its decision on results from the phase 1\/2 REFOCUS trial, which enrolled 116 patients with unresectable or <a rel=\"noopener noreferrer\" href=\"https:\/\/www.healio.com\/news\/hematology-oncology\/20260122\/mental-health-disorders-could-significantly-increase-risk-for-developing-liver-cancer\" id=\"rId11\" target=\"_blank\">metastatic cholangiocarcinoma<\/a> who had received prior chemotherapy or chemoimmunotherapy but had not previously received an FGFR inhibitor.<\/p>\n<p>Patients received 70 mg lirafugratinib orally once daily until disease progression or unacceptable toxicity.<\/p>\n<p>Results showed an ORR of 46% (95% CI, 36%-55%), with a median duration of response of 11.8 months (95% CI, 7.5-13).<\/p>\n<p>Prescribing information for lirafugratinib includes warnings and precautions for ocular toxicity, hyperphosphatemia and soft tissue mineralization, and embryo-fetal toxicity. <\/p>\n<p>The recommended dose is 70 mg orally taken once daily until disease progression or unacceptable toxicity.<\/p>\n<p>The FDA granted lirafugratinib priority review, adding to its earlier breakthrough therapy and orphan drug designations.<\/p>\n<div class=\"article__content--footer\">\n<div class=\"publisher-logo\">\n    <span>Published by:<\/span><br \/>\n    <img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/hot.svg?la=en&amp;h=24&amp;w=141&amp;hash=2F86D471C8514C0E334E329AA799E8B4\" class=\"logo-img\" height=\"24\" alt=\"hemonc today logo\" width=\"141\"\/>\n  <\/div>\n<p><!-- Healio AI Widget --><\/p>\n<div class=\"healio-ai-component-inline\" data-no-ads=\"true\" data-module-track-category=\"Healio AI\" data-module-track-action=\"Click\" data-module-track-label=\"Access Healio Ai from component - News_AI Component - In-Content (all devices)\">\n<div class=\"healio-ai-content\">\n    <img decoding=\"async\" src=\"https:\/\/m3.healio.com\/~\/media\/images\/healio-ai\/healio-ai_logo.svg\" alt=\"Healio AI\" class=\"healio-ai-logo\"\/><\/p>\n<p><strong>Ask a clinical question<\/strong> and tap into <strong>Healio AI&#8217;s knowledge<\/strong> base.<\/p>\n<ul>&#13;<\/p>\n<li>PubMed, enrolling\/recruiting trials, guidelines<\/li>\n<p>&#13;<\/p>\n<li>Clinical Guidance, Healio CME, FDA news<\/li>\n<p>&#13;<\/p>\n<li>Healio&#8217;s exclusive daily news coverage of clinical data<\/li>\n<p>&#13;\n    <\/ul>\n<p>    <button class=\"healio-ai-button\" onclick=\"window.location.href=\" https:=\"\">Learn more<\/button>\n  <\/div>\n<\/div>\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse u110bc190ccb54f9badeb3b345069fd57\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. Please try again later. If you continue to have this issue please contact <a href=\"https:\/\/www.healio.com\/news\/hematology-oncology\/20260923\/mailto:customerservice@slackinc.com\">customerservice@slackinc.com<\/a>.<\/strong>  <\/p>\n<p><button data-dismiss=\"modal\" class=\"btn btn-primary btn-lg btn-block\">Back to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<p><br \/>\n<br \/><a href=\"https:\/\/www.healio.com\/news\/hematology-oncology\/20260923\/lyrfigtu-gains-fda-approval-for-previously-treated-cholangiocarcinoma-with-fgfr2-mutation\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>September 23, 2026 1 min read &#13; &#13; &#13; Add topic to email alerts&#13; &#13; &#13; Receive an email when new articles are posted on &#13; Please provide your email address to receive an email when new articles are posted on . &#8220;&#13; data-action=&#8221;subscribe&#8221;&gt;&#13; Subscribe&#13; We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: FDA approved Lyrfigtu for previously treated FGFR2-mutated unresectable, locally advanced or metastatic cholangiocarcinoma. REFOCUS trial data showed a 46% ORR and an 11.8-month median duration of response. The FDA approved lirafugratinib \u2014 a kinase inhibitor \u2014 for adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma. The indication for lirafugratinib (Lyrfigtu, Elevar Therapeutics) applies to patients with a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement. &#13; &#13;&#13;&#13;&#13;&#13;&#13; &#13; &#13; &#13;&#13; The FDA approved lirafugratinib \u2014 a kinase inhibitor \u2014 for adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma. &#13; &#13; The FDA based its decision on results from the phase 1\/2 REFOCUS trial, which enrolled 116 patients with unresectable or metastatic cholangiocarcinoma who had received prior chemotherapy or chemoimmunotherapy but had not previously received an FGFR inhibitor. Patients received 70 mg lirafugratinib orally once daily until disease progression or unacceptable toxicity. Results showed an ORR of 46% (95% CI, 36%-55%), with a median duration of response of 11.8 months (95% CI, 7.5-13). Prescribing information for lirafugratinib includes warnings and precautions for ocular toxicity, hyperphosphatemia and soft tissue mineralization, and embryo-fetal toxicity. The recommended dose is 70 mg orally taken once daily until disease progression or unacceptable toxicity. The FDA granted lirafugratinib priority review, adding to its earlier breakthrough therapy and orphan drug designations. Published by: Ask a clinical question and tap into Healio AI&#8217;s knowledge base. &#13; PubMed, enrolling\/recruiting trials, guidelines &#13; Clinical Guidance, Healio CME, FDA news &#13; Healio&#8217;s exclusive daily news coverage of clinical data &#13; Learn more &#13; &#13; &#13; Add topic to email alerts&#13; &#13; &#13; Receive an email when new articles are posted on &#13; Please provide your email address to receive an email when new articles are posted on . &#8220;&#13; data-action=&#8221;subscribe&#8221;&gt;&#13; Subscribe&#13; We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. 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