{"id":719,"date":"2025-12-09T06:26:00","date_gmt":"2025-12-09T14:26:00","guid":{"rendered":"https:\/\/getasecondopinion.ai\/blog\/?p=719"},"modified":"2025-12-08T23:27:29","modified_gmt":"2025-12-09T07:27:29","slug":"fda-approves-breyanzi-for-relapsed-or-refractory-marginal-zone-lymphoma","status":"publish","type":"post","link":"https:\/\/www.getasecondopinion.ai\/blog\/medications\/new-drugs\/fda-approves-breyanzi-for-relapsed-or-refractory-marginal-zone-lymphoma\/","title":{"rendered":"FDA Approves Breyanzi for Relapsed or Refractory Marginal Zone Lymphoma"},"content":{"rendered":"\n<p>The U.S. Food and Drug Administration approved Breyanzi for adults with relapsed or refractory marginal zone lymphoma who have already tried at least two prior systemic therapies. This approval expands the list of cancers for which Breyanzi is authorized and gives patients a new option when other treatments have failed.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>In plain language: what is Breyanzi?<\/strong><\/h3>\n\n\n\n<p>Breyanzi is a CAR\u2011T cell therapy&nbsp; &#8211;&nbsp; doctors take a patient\u2019s own T cells, reprogram them in a lab to recognize a protein called CD19 on certain lymphoma cells, grow billions of those engineered cells, then infuse them back into the patient so they can hunt down and kill the cancer. Think of it as training a patient\u2019s immune system to be a targeted cancer-fighting squad.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>How well does it work?<\/strong><\/h3>\n\n\n\n<p>Different ways of counting responses were reported in the studies:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>In the <strong><em>i<\/em><\/strong>ntention\u2011to\u2011treat analysis, the overall response rate (ORR) was about 84%, with a complete response (CR) rate near 56%.<\/li>\n\n\n\n<li>In the treated\/evaluable group reported by the company, the ORR was 95.5% and CR 62.1%\u00a0 &#8211;\u00a0 numbers that show deep responses in many patients who received the product as intended.<\/li>\n<\/ul>\n\n\n\n<p>Both sets of numbers are encouraging because they show many patients\u2019 tumors shrank or became undetectable after a single infusion, and many responses were durable over time.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Safety&nbsp; &#8211;&nbsp; what to watch for<\/strong><\/h3>\n\n\n\n<p>Breyanzi can cause serious side effects, the most important being cytokine release syndrome (CRS) and neurologic toxicities (confusion, seizures, etc.). Other risks include infections, low blood counts, and immune system changes that can make infections more likely. These risks mean treatment is done at specialized centers with experience managing CAR\u2011T side effects.<\/p>\n\n\n\n<div class=\"wp-block-group unauthenticated invisible has-global-padding is-layout-constrained wp-container-core-group-is-layout-675f737c wp-block-group-is-layout-constrained\" style=\"padding-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30)\">\n<div class=\"wp-block-group cta-background has-background has-global-padding is-content-justification-left is-layout-constrained wp-container-core-group-is-layout-64f51f8a wp-block-group-is-layout-constrained\" style=\"border-style:none;border-width:0px;border-radius:30px;background-color:#fff6eb;padding-top:var(--wp--preset--spacing--30);padding-right:var(--wp--preset--spacing--30);padding-bottom:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30);box-shadow:var(--wp--preset--shadow--natural);background-image:url(&apos;https:\/\/getasecondopinion.ai\/blog\/wp-content\/uploads\/2025\/10\/cta-background-02.webp&apos;);background-position:100% 100%;background-repeat:no-repeat;background-size:contain;background-attachment:scroll;\">\n<div class=\"wp-block-group has-global-padding is-layout-constrained wp-container-core-group-is-layout-9d2deb30 wp-block-group-is-layout-constrained\" style=\"padding-top:0px;padding-right:0px;padding-bottom:10px\">\n<h3 class=\"wp-block-heading has-text-align-center has-accent-1-color has-text-color has-link-color has-large-font-size wp-elements-e1a2b4d20c009cbe1ac01729b645a8a1\">Experiencing Side Effects? <br>Let\u2019s Rethink Your Meds.<\/h3>\n\n\n\n<p>Explore treatment options that may work better for your body &#8211; with fewer side effects and lower costs. It\u2019s fast, free, and tailored to you. <strong><a href=\"https:\/\/getasecondopinion.ai\/intro-summary\" target=\"_blank\" rel=\"noreferrer noopener\">Learn More \u2192<\/a><\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Quick facts&nbsp;<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><\/td><td><strong>What it means<\/strong><\/td><td><strong>Key number<\/strong><\/td><\/tr><tr><td>Type<\/td><td>CAR\u2011T cell therapy<\/td><td>One\u2011time infusion<\/td><\/tr><tr><td>Approval use<\/td><td>Adults with relapsed\/refractory MZL after \u22652 therapies<\/td><td>FDA approved Dec 2025<\/td><\/tr><tr><td>Main risks<\/td><td>Immune reaction and neurologic effects<\/td><td>CRS and neurotoxicity possible<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Why this matters<\/strong><\/h3>\n\n\n\n<p>For people with MZL who have run out of standard options, Breyanzi offers a potentially powerful, single\u2011treatment approach that can produce deep remissions. But it\u2019s not a simple pill&nbsp; &#8211;&nbsp; it\u2019s complex, requires specialized care, and carries serious risks that need close monitoring.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Next steps if you or a loved one are interested<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Talk to a lymphoma specialist about eligibility and what to expect.<\/li>\n\n\n\n<li>Ask whether the treatment center has CAR\u2011T experience and how they handle CRS and neurologic events.<\/li>\n\n\n\n<li>Check insurance coverage and patient support programs; manufacturers often offer help navigating access and logistics.<\/li>\n<\/ul>\n\n\n\n<div class=\"wp-block-group unauthenticated invisible has-global-padding is-layout-constrained wp-container-core-group-is-layout-675f737c wp-block-group-is-layout-constrained\" style=\"padding-right:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30)\">\n<div class=\"wp-block-group cta-background has-custom-off-white-background-color has-background has-global-padding is-content-justification-left is-layout-constrained wp-container-core-group-is-layout-64f51f8a wp-block-group-is-layout-constrained\" style=\"border-style:none;border-width:0px;border-radius:30px;padding-top:var(--wp--preset--spacing--30);padding-right:var(--wp--preset--spacing--30);padding-bottom:var(--wp--preset--spacing--30);padding-left:var(--wp--preset--spacing--30);box-shadow:var(--wp--preset--shadow--natural);background-image:url(&apos;https:\/\/getasecondopinion.ai\/blog\/wp-content\/uploads\/2025\/09\/cta-background-01.webp&apos;);background-position:100% 100%;background-repeat:no-repeat;background-size:contain;background-attachment:scroll;\">\n<div class=\"wp-block-group has-global-padding is-layout-constrained wp-container-core-group-is-layout-153751c2 wp-block-group-is-layout-constrained\" style=\"padding-bottom:10px\">\n<h3 class=\"wp-block-heading has-text-align-center has-accent-1-color has-text-color has-link-color has-large-font-size wp-elements-b6fe6b9c1e90c3ca0e3d22a4a0e21d9e\">Better Treatment, Lower Cost &#8211; No Catch.<\/h3>\n\n\n\n<p>Find safer, more effective medications with fewer side effects &#8211; often for less money. It\u2019s fast, free, and personalized. <strong><a href=\"https:\/\/getasecondopinion.ai\/intro-summary\" target=\"_blank\" rel=\"noreferrer noopener\">Learn More \u2192<\/a><\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>References (3)<\/strong><\/h3>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong>FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma<\/strong> <a href=\"https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma\">https:\/\/www.fda.gov\/drugs\/resources-information-approved-drugs\/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma<\/a><\/li>\n\n\n\n<li><strong>FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US<\/strong> <a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-car-t-cell-therapy-marginal-zone-lymphoma-us\">https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-car-t-cell-therapy-marginal-zone-lymphoma-us<\/a>\u00a0\u00a0<\/li>\n\n\n\n<li><strong>Bristol Myers Squibb\u2019s Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL)<\/strong> <a href=\"https:\/\/news.bms.com\/news\/corporate-financial\/2025\/Bristol-Myers-Squibbs-Breyanzi-Approved-by-the-U-S--FDA-as-the-First-and-Only-CAR-T-Cell-Therapy-for-Adults-with-Relapsed-or-Refractory-Marginal-Zone-Lymphoma-MZL\/default.aspx\">https:\/\/news.bms.com\/news\/corporate-financial\/2025\/Bristol-Myers-Squibbs-Breyanzi-Approved-by-the-U-S&#8211;FDA-as-the-First-and-Only-CAR-T-Cell-Therapy-for-Adults-with-Relapsed-or-Refractory-Marginal-Zone-Lymphoma-MZL\/default.aspx<\/a>\u00a0\u00a0<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration approved Breyanzi for adults with relapsed or refractory marginal zone lymphoma who have already tried at least two prior systemic therapies. This approval expands the list of cancers for which Breyanzi is authorized and gives patients a new option when other treatments have failed. In plain language: what is [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":720,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[35],"tags":[464,467,468,472,463,371,465,469,470,466],"class_list":["post-719","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-new-drugs","tag-breyanzi","tag-breyanzi-side-effects","tag-cancer-treatment-news","tag-car-t-cell-therapy","tag-car-t-therapy","tag-fda-approval","tag-lisocabtagene-maraleucel","tag-marginal-zone-lymphoma","tag-oncology-update","tag-patient-guide"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Approves Breyanzi for Relapsed or Refractory Marginal Zone Lymphoma - Get a Second Opinion<\/title>\n<meta name=\"description\" content=\"FDA approves Breyanzi for relapsed marginal zone lymphoma offering 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