{"id":3119,"date":"2023-11-19T23:59:40","date_gmt":"2023-11-19T23:59:40","guid":{"rendered":"http:\/\/drhimanshuyadav.com\/fda-approves-fluzakura-for-treatment-of-refractory-metastatic-colorectal-cancer\/"},"modified":"2023-11-19T23:59:40","modified_gmt":"2023-11-19T23:59:40","slug":"fda-approves-fluzakura-for-treatment-of-refractory-metastatic-colorectal-cancer","status":"publish","type":"post","link":"https:\/\/drhimanshuyadav.com\/blog\/fda-approves-fluzakura-for-treatment-of-refractory-metastatic-colorectal-cancer\/","title":{"rendered":"FDA approves Fluzakura for treatment of refractory metastatic colorectal cancer"},"content":{"rendered":"<div data-component=\"ArticleContent\">\n<div class=\"article__content--header\">\n<div class=\"article__posted-date\">\n<p>    November 9, 2023 <\/p>\n<p>    2 minute read <\/p>\n<\/p><\/div>\n<\/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 loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/hot.svg?h=24&amp;w=141&amp;la=en&amp;hash=2F86D471C8514C0E334E329AA799E8B4\" height=\"24\" width=\"141\" class=\"logo-img\" alt=\"Hemonk today's logo\"\/>\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=\"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\"\/>Add topics to email alerts<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse u8bcd0c5738d243458ebb1c1158de2d8e\">\n<div class=\"email-alert-dialogue\">\n<p>Receive an email when a new article is posted <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n<p>          Enter your email address to receive emails when new articles are posted. <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=\"\">&#8221; data-action=&#8221;subscribe&#8221;> Subscribe<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>Your request could not be processed. Please try again later. If you continue to experience this issue, please contact us at customerservice@slackinc.com.<\/strong>  <\/p>\n<p><button data-dismiss=\"modal\" class=\"btn btn-primary btn-lg btn-block\">Return to Helio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<p>The FDA has approved fruquintinib for certain adults with previously treated metastatic colorectal cancer.<\/p>\n<p>This indication applies to the use of this drug in adults who have previously received fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapy, or anti-VEGF therapy. <em>RAS<\/em> Wild-type and medically relevant anti-EGFR therapy.<\/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\/stock-images\/hemonc\/f\/fdasign_323811316.webp?w=476\" media=\"(max-width: 768px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/hemonc\/f\/fdasign_323811316.webp?w=800\" media=\"(max-width: 992px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/hemonc\/f\/fdasign_323811316.webp?w=595\" media=\"(max-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/hemonc\/f\/fdasign_323811316.webp?w=476\" media=\"(min-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/hemonc\/f\/fdasign_323811316.webp?w=476\">&#13;<br \/>\n&#13;<br \/>\n      <img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/hemonc\/f\/fdasign_323811316.jpg?w=800\" alt=\"FDA Headquarters in Washington\" class=\"figure-img img-fluid\" width=\"800\"\/>&#13;<br \/>\n    <\/source><\/source><\/source><\/source><\/source><\/picture>&#13;<figcaption class=\"figure-caption\">The FDA has approved Fluzakura for certain adults with metastatic colorectal cancer. <i>Source: Adobe Stock.<\/i>&#13;<br \/>\n    <\/figcaption>&#13;<br \/>\n  <\/figure>\n<p>Fruquintinib (Fruzakura, Takeda Pharmaceutical Co., Ltd.) is an oral tyrosine kinase inhibitor of VEGF receptors 1, 2, and 3 that was previously granted Fast Track designation and review by the FDA for the indication of refractory metastatic colorectal cancer. It is. <\/p>\n<p>&#8220;Patients with metastatic disease are often frail and fatigued, both due to their condition and the treatments they have received. Oral chemotherapy provides a survival benefit despite treatment with previous therapies. &#8220;A non-invasive option is critically needed for the treatment of metastatic colorectal cancer.&#8221; <strong>Kathy Eng <\/strong><strong>M<\/strong><strong>D.F.A.C.P.<\/strong> Co-Director of Gastrointestinal Oncology at Vanderbilt University Medical Center said in a Takeda press release. <\/p>\n<p>&#8220;Colorectal cancer is a highly heterogeneous disease, making it difficult to make progress in patients whose cancer has spread,&#8221; Eng added.  \u201cWe look forward to bringing new solutions to the right patients.\u201d<\/p>\n<p>The FDA granted approval based on the results of two randomized Phase 3 trials, FRESCO and FRESCO-2. <\/p>\n<p>The placebo-controlled FRESCO study evaluated fruquintinib in 416 Chinese adults with previously treated metastatic colorectal cancer whose disease progressed during or after fluoropyrimidine, oxaliplatin, or irinotecan-based chemotherapy. Safety and efficacy were evaluated. The double-blind, placebo-controlled FRESCO-2 study tested fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapy, anti-VEGF biological therapy, anti-VEGF biological therapy, anti-VEGF biological therapy, anti-VEGF biological Fruquintinib was evaluated in 691 adults with previously treated metastatic colorectal cancer who experienced disease progression during or after chemotherapy and previous fluoropyrimidine, oxaliplatin, or irinotecan-based chemotherapy. For EGFR biological therapy <em>RAS<\/em> wild type, and at least one of trifluridine\/tipiracil or regorafenib.<\/p>\n<p>Researchers randomly assigned participants in both studies in a 2:1 ratio to receive fruquintinib 5 mg orally once daily or placebo plus best supportive care for the first 21 days of each 28-day cycle. assigned to groups. Study participants were treated until their disease progressed or they experienced unacceptable toxicity. <\/p>\n<p>Results from the FRESCO trial showed median OS in the fruquintinib group was 9.3 months (95% CI, 8.2 to 10.5) compared with 6.6 months (95% CI, 5.9 to 8.1) in the placebo group (HR = 0.65, 95% CI).  , 0.51-0.83).  Further results from FRESCO-2 showed median OS in the fruquintinib arm was 7.4 months (95% CI, 6.78.2) compared to 4.8 months (95% CI, 4-5.8) in the placebo arm. (HR=0.66, 95%).  CI, 0.55-0.8<\/p>\n<p>The most common adverse events associated with fruquintinib use in >20% of patients included hypertension, palmar-plantar red blood cell dysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.<\/p>\n<h4>      <strong>References: <\/strong>    <\/h4>\n<div class=\"publisher-logo\">\n    <span>Issuer:<\/span><br \/>\n    <img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/hot.svg?h=24&amp;w=141&amp;la=en&amp;hash=2F86D471C8514C0E334E329AA799E8B4\" class=\"logo-img\" width=\"141\" height=\"24\" alt=\"Hemonk today's logo\"\/>\n  <\/div>\n<div class=\"article__content--footer\">\n<div class=\"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\"\/>Add topics to email alerts<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse u8bcd0c5738d243458ebb1c1158de2d8e\">\n<div class=\"email-alert-dialogue\">\n<p>Receive an email when a new article is posted <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n<p>          Enter your email address to receive emails when new articles are posted. <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=\"\">&#8221; data-action=&#8221;subscribe&#8221;> Subscribe<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>Your request could not be processed. 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