{"id":7785,"date":"2024-03-18T21:58:31","date_gmt":"2024-03-18T13:58:31","guid":{"rendered":"https:\/\/flcube.com\/?p=7785"},"modified":"2024-11-13T23:08:52","modified_gmt":"2024-11-13T15:08:52","slug":"bristol-myers-squibbs-breyanzi-receives-fda-accelerated-approval-for-cll-sll-treatment","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=7785","title":{"rendered":"Bristol Myers Squibb’s Breyanzi Receives FDA Accelerated Approval for CLL\/SLL Treatment"},"content":{"rendered":"\n

The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb\u2019s (BMS; NYSE: BMY<\/a>) CAR-T cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have undergone at least two prior lines of therapy. This marks the first indication extension for a CAR-T product and adds to Breyanzi\u2019s existing approval for the second-line treatment of relapsed or refractory large B-cell lymphoma (LBCL).<\/p>\n\n\n\n

The FDA\u2019s decision was supported by Phase I\/II clinical data, which demonstrated that the CD19-directed therapy achieved a complete response (CR) rate of 20%, an objective response rate (ORR) of 45%, and a median duration of response of 35.3 months. While cytokine release syndrome (CRS) and neurologic events (NEs) were observed in 83% and 46% of patients respectively, grade 3 or higher occurrences were noted in only 9% and 21% of participants respectively.- Flcube.com<\/a><\/p>\n\n\n\n

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The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb\u2019s…<\/p>\n","protected":false},"author":1,"featured_media":0,"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":false,"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-7785","post","type-post","status-publish","format-standard","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":"\nBristol Myers Squibb's Breyanzi Receives FDA Accelerated Approval for CLL\/SLL Treatment - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb\u2019s (BMS; NYSE: BMY) CAR-T cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have undergone at least two prior lines of therapy. 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