{"id":34146,"date":"2025-05-26T16:01:51","date_gmt":"2025-05-26T08:01:51","guid":{"rendered":"https:\/\/flcube.com\/?p=34146"},"modified":"2025-05-26T16:01:52","modified_gmt":"2025-05-26T08:01:52","slug":"gsks-blenrep-recommended-for-eu-approval-in-multiple-myeloma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=34146","title":{"rendered":"GSK’s Blenrep Recommended for EU Approval in Multiple Myeloma"},"content":{"rendered":"\n

UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK<\/a>) announced that its Blenrep (belantamab mafodotin) has been recommended for market approval by the European Medicines Agency’s Medicinal Products for Human Use (CHMP). The recommendation supports the use of Blenrep in combination with bortezomib plus dexamethasone (BVd) for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy. It is also endorsed for use with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy, including lenalidomide. The European Commission’s final decision is anticipated in Q3 2025, following recent approvals by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025 and Japan’s Ministry of Health, Labour and Welfare (MHLW) in May 2025.<\/p>\n\n\n\n

Clinical Trial Results<\/strong>
The CHMP’s positive recommendation is based on results from the pivotal Phase III DREAMM-7 and DREAMM-8 trials. These trials demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) for Blenrep combinations compared to standard therapies. Additionally, DREAMM-7 showed improved overall survival (OS) when compared to a daratumumab-based triplet.<\/p>\n\n\n\n

Blenrep Mechanism<\/strong>
Blenrep is the world\u2019s first and only BCMA-targeted antibody drug conjugate (ADC). It consists of a humanized anti-BCMA monoclonal antibody linked to the cytotoxic agent auristatin F via a non-cleavable linker. This innovative design allows for simplified administration, making it suitable for use across various healthcare settings, including primary care.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that its Blenrep (belantamab mafodotin) has been…<\/p>\n","protected":false},"author":1,"featured_media":34147,"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-34146","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":"\nGSK's Blenrep Recommended for EU Approval in Multiple Myeloma - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that its Blenrep (belantamab mafodotin) has been recommended for market approval by the European Medicines Agency's Medicinal Products for Human Use (CHMP). The recommendation supports the use of Blenrep in combination with bortezomib plus dexamethasone (BVd) for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy. It is also endorsed for use with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy, including lenalidomide. The European Commission's final decision is anticipated in Q3 2025, following recent approvals by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025 and Japan's Ministry of Health, Labour and Welfare (MHLW) in May 2025.\" \/>\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=34146\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GSK's Blenrep Recommended for EU Approval in Multiple Myeloma\" \/>\n<meta property=\"og:description\" content=\"UK-based pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) announced that its Blenrep (belantamab mafodotin) has been recommended for market approval by the European Medicines Agency's Medicinal Products for Human Use (CHMP). The recommendation supports the use of Blenrep in combination with bortezomib plus dexamethasone (BVd) for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy. It is also endorsed for use with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy, including lenalidomide. 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