{"id":36308,"date":"2025-07-01T00:35:57","date_gmt":"2025-06-30T16:35:57","guid":{"rendered":"https:\/\/flcube.com\/?p=36308"},"modified":"2025-07-01T00:35:58","modified_gmt":"2025-06-30T16:35:58","slug":"bms-secures-fda-approval-for-updated-labels-of-breyanzi-and-abecma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=36308","title":{"rendered":"BMS Secures FDA Approval for Updated Labels of Breyanzi and Abecma"},"content":{"rendered":"\n

US major Bristol-Myers Squibb (BMS; NYSE: BMY<\/a>) announced that the US Food and Drug Administration (FDA) has approved label updates for its chimeric antigen-receptor (CAR)-T cell therapies Breyanzi (lisocabtagene maraleucel; liso-cel) and Abecma (idecabtagene vicleucel; ide-cel). These updates remove specific patient monitoring requirements and Risk Evaluation and Mitigation Strategy (REMS) programs, streamlining the treatment process for large B-cell lymphoma (LBCL) and multiple myeloma patients.<\/p>\n\n\n\n

Label Updates and Impact<\/strong>
The revised labels eliminate previously required patient monitoring protocols and REMS programs that were in place since the initial approval of both therapies. These changes are designed to reduce the burden on healthcare delivery systems and improve accessibility for patients and caregivers, particularly those located far from certified cellular therapy centers.<\/p>\n\n\n\n

Expanding Access and Geographic Reach<\/strong>
BMS is actively working to expand the geographic availability of its cell therapies. The company is increasing efforts to enhance access to Breyanzi and Abecma by integrating more community cancer centers into its network, bringing treatment closer to patients.<\/p>\n\n\n\n

Therapy Details<\/strong>
Breyanzi is indicated for adult patients with large B-cell lymphoma (LBCL), encompassing diffuse large B-cell lymphoma not otherwise specified (DLBCL), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Abecma is designated for adult patients with relapsed or refractory multiple myeloma who have undergone two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

US major Bristol-Myers Squibb (BMS; NYSE: BMY) announced that the US Food and Drug Administration…<\/p>\n","protected":false},"author":1,"featured_media":36309,"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":[429,428,16,21,77,849,15],"class_list":["post-36308","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-bms","tag-bristol-myers-squibb","tag-cancer","tag-car-t","tag-cell-therapy","tag-nyse-bmy","tag-product-approvals"],"yoast_head":"\nBMS Secures FDA Approval for Updated Labels of Breyanzi and Abecma - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"US major Bristol-Myers Squibb (BMS; NYSE: BMY) announced that the US Food and Drug Administration (FDA) has approved label updates for its chimeric antigen-receptor (CAR)-T cell therapies Breyanzi (lisocabtagene maraleucel; liso-cel) and Abecma (idecabtagene vicleucel; ide-cel). 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