{"id":38000,"date":"2025-07-28T12:22:41","date_gmt":"2025-07-28T04:22:41","guid":{"rendered":"https:\/\/flcube.com\/?p=38000"},"modified":"2025-07-28T12:22:42","modified_gmt":"2025-07-28T04:22:42","slug":"gsks-blenrep-approved-in-eu-for-relapsed-or-refractory-multiple-myeloma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=38000","title":{"rendered":"GSK&#8217;s Blenrep Approved in EU for Relapsed or Refractory Multiple Myeloma"},"content":{"rendered":"\n<p>UK-based GlaxoSmithKline (GSK; <a href=\"https:\/\/www.google.com\/finance\/quote\/GSK:NYSE\">NYSE: GSK<\/a>) announced today that Blenrep has received European Union (EU) approval for two indications: in combination with bortezomib and dexamethasone (BVd) for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy; or in combination with pomalidomide and dexamethasone (BPd) for adult patients with RRMM who have received at least one prior therapy, including lenalidomide-containing treatment.<\/p>\n\n\n\n<p><strong>Drug Mechanism and Technology<\/strong><br>Blenrep is an antibody-drug conjugate (ADC) that combines a humanized anti-BCMA monoclonal antibody with the cytotoxic agent auristatin F via a non-cleavable linker. The linker technology is licensed from Seagen Inc., while the monoclonal antibody is produced using POTELLIGENT technology licensed from BioWa Inc., a subsidiary of Kyowa Kirin Group.<\/p>\n\n\n\n<p><strong>Clinical Trial Results<\/strong><br>The DREAMM-7 and DREAMM-8 studies demonstrated that Blenrep-related ocular side effects can be effectively managed and reversed through appropriate dose adjustments and follow-up. Discontinuation rates due to ocular side effects were low (\u22649%). The most commonly reported non-ocular adverse events (incidence &gt;30%) were thrombocytopenia (87%) and diarrhea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%), and COVID-19 infection (37%) in DREAMM-8.<\/p>\n\n\n\n<p><strong>Global Approval and Market Expansion<\/strong><br>Blenrep combination regimens have also been approved in the UK, Japan, and other markets, including Canada and Switzerland. These approvals are based on the DREAMM-8 study results. The regimen is currently under review in all major global markets, including the U.S. and China. In the U.S., the combination therapy received breakthrough therapy designation and its marketing application was granted priority review status based on DREAMM-7 results.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced today that Blenrep has received European Union (EU) approval&#8230;<\/p>\n","protected":false},"author":1,"featured_media":38001,"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":[1],"tags":[278,184,914],"class_list":["post-38000","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","tag-glaxosmithkline","tag-gsk","tag-nyse-gsk"],"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&#039;s Blenrep Approved in EU for Relapsed or Refractory Multiple Myeloma - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced today that Blenrep has received European Union (EU) approval for two indications: in combination with bortezomib and dexamethasone (BVd) for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy; or in combination with pomalidomide and dexamethasone (BPd) for adult patients with RRMM who have received at least one prior therapy, including lenalidomide-containing treatment.\" \/>\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=38000\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GSK&#039;s Blenrep Approved in EU for Relapsed or Refractory Multiple Myeloma\" \/>\n<meta property=\"og:description\" content=\"UK-based GlaxoSmithKline (GSK; NYSE: GSK) announced today that Blenrep has received European Union (EU) approval for two indications: in combination with bortezomib and dexamethasone (BVd) for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy; or in combination with pomalidomide and dexamethasone (BPd) for adult patients with RRMM who have received at least one prior therapy, including lenalidomide-containing treatment.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/flcube.com\/?p=38000\" \/>\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=\"2025-07-28T04:22:41+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-07-28T04:22:42+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/flcube.com\/wp-content\/uploads\/2025\/07\/2804.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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