{"id":44324,"date":"2025-10-24T23:33:21","date_gmt":"2025-10-24T15:33:21","guid":{"rendered":"https:\/\/flcube.com\/?p=44324"},"modified":"2025-10-24T23:33:22","modified_gmt":"2025-10-24T15:33:22","slug":"gsk-secures-fda-approval-for-blenrep-in-multiple-myeloma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=44324","title":{"rendered":"GSK Secures FDA Approval for Blenrep in Multiple Myeloma"},"content":{"rendered":"\n<p>GlaxoSmithKline (GSK, <a href=\"https:\/\/www.google.com\/finance\/quote\/GSK:NYSE\">NYSE: GSK<\/a>) announced today that the U.S. Food and Drug Administration (FDA) has approved <strong>Blenrep (belantamab\u202fmafodotin\u2011blmf)<\/strong> in combination with <strong>bortezomib and dexamethasone (BVd)<\/strong> for the treatment of adult patients with <strong>relapsed or refractory multiple myeloma<\/strong> who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-key-highlights\">Key Highlights<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Approved Indication<\/strong><\/td><td>3L+ relapsed\/refractory MM patients (\u22652 prior PI\u202f+\u202fIMID)<\/td><\/tr><tr><td><strong>Clinical Benefit<\/strong><\/td><td>51\u202f% reduction in risk of death; median PFS 31.3\u202fmonths vs 10.3\u202fmonths with daratumumab\u2011based DVd<\/td><\/tr><tr><td><strong>Safety Profile<\/strong><\/td><td>Consistent with known profiles of Blenrep, bortezomib, and dexamethasone<\/td><\/tr><tr><td><strong>Regulatory Milestone<\/strong><\/td><td>First FDA approval of Blenrep in a lower\u2011line setting since 2020<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-background-on-blenrep\"><strong>Background on Blenrep<\/strong><\/h2>\n\n\n\n<p>Blenrep is a <strong>targeted antibody\u2011drug conjugate (ADC)<\/strong> that binds B\u2011cell maturation antigen (BCMA) and delivers the cytotoxic auristatin\u202fF via a non\u2011cleavable linker. The technology was licensed from <strong>Seagen Inc.<\/strong> and <strong>Kyowa Kirin Group<\/strong>, enabling rapid clinical development.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Initial U.S.\/EU Approval (2020)<\/strong> \u2013 4L+ relapsed\/refractory MM (anti\u2011CD38\u202f+\u202fPI\u202f+\u202fIMID).<\/li>\n\n\n\n<li><strong>Withdrawal (2022)<\/strong> \u2013 Due to the Phase\u202fIII DREAMM\u20113 study failing to hit its primary endpoint.<\/li>\n\n\n\n<li><strong>Current Approval (2025)<\/strong> \u2013 Supported by the pivotal <strong>DREAMM\u20117<\/strong> Phase\u202fIII trial, which demonstrated the robust survival benefit outlined above.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-dreamm-7-trial-snapshot\"><strong>DREAMM\u20117 Trial Snapshot<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Metric<\/th><th>Blenrep\u202f+\u202fBVd<\/th><th>Daratumumab\u202f+\u202fBVd (DVd)<\/th><\/tr><\/thead><tbody><tr><td>Median PFS<\/td><td>31.3\u202fmonths<\/td><td>10.3\u202fmonths<\/td><\/tr><tr><td>Hazard Ratio (Death)<\/td><td>0.49 (51\u202f% reduction)<\/td><td>\u2014<\/td><\/tr><tr><td>3\u2011Year Overall Survival<\/td><td>74.5\u202f%<\/td><td>59.2\u202f%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The study enrolled over 1,200 patients across 45 sites in North America, Europe, and Asia, providing a robust global evidence base.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-strategic-implications-for-gsk\"><strong>Strategic Implications for GSK<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Portfolio Strengthening<\/strong> \u2013 Expands GSK\u2019s high\u2011growth MM offering.<\/li>\n\n\n\n<li><strong>Commercial Opportunity<\/strong> \u2013 Access to a sizable U.S. patient cohort (~45,000 annually) with unmet need.<\/li>\n\n\n\n<li><strong>Future Development<\/strong> \u2013 GSK plans to explore earlier\u2011line combinations and synergy with next\u2011generation immunotherapies.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-forward-looking-statements\">Forward\u2011Looking Statements<\/h3>\n\n\n\n<p>This release contains forward\u2011looking statements that involve risks and uncertainties. Actual results may differ materially.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>GlaxoSmithKline (GSK, NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has&#8230;<\/p>\n","protected":false},"author":1,"featured_media":44325,"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":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[35,16,278,184,914,15],"class_list":["post-44324","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-adc-xdc","tag-cancer","tag-glaxosmithkline","tag-gsk","tag-nyse-gsk","tag-product-approvals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>GSK Secures FDA Approval for Blenrep in Multiple Myeloma - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"GlaxoSmithKline (GSK, NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved Blenrep (belantamab\u202fmafodotin\u2011blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.\" \/>\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=44324\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GSK Secures FDA Approval for Blenrep in Multiple Myeloma\" \/>\n<meta property=\"og:description\" content=\"GlaxoSmithKline (GSK, NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved Blenrep (belantamab\u202fmafodotin\u2011blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=44324\" \/>\n<meta property=\"og:site_name\" content=\"Insight, China&#039;s Pharmaceutical Industry\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=61566606313834\" \/>\n<meta property=\"article:published_time\" content=\"2025-10-24T15:33:21+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-10-24T15:33:22+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/10\/2409.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1080\" \/>\n\t<meta property=\"og:image:height\" content=\"608\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Fineline Cube\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:description\" content=\"Navigate the complexities of China\u2019s pharmaceutical industry with precision and clarity. 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