{"id":3343,"date":"2024-05-31T09:16:32","date_gmt":"2024-05-31T01:16:32","guid":{"rendered":"https:\/\/flcube.com\/?p=3343"},"modified":"2024-11-13T23:08:13","modified_gmt":"2024-11-13T15:08:13","slug":"fda-extends-indication-for-bms-car-t-therapy-breyanzi-to-include-relapsed-mcl-in-adults","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=3343","title":{"rendered":"FDA Extends Indication for BMS&#8217; CAR-T Therapy Breyanzi to Include Relapsed MCL in Adults"},"content":{"rendered":"\n<p>The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; <a href=\"https:\/\/www.google.com\/finance\/quote\/BMY:NYSE\">NYSE: BMY<\/a>) an indication extension approval for its CAR-T therapy Breyanzi (lisocabtagene maraleucel). The therapy is now approved as a treatment for relapsed or refractory mantle cell lymphoma (MCL) in adults who have received at least two prior lines of systemic therapy. Breyanzi is also indicated for other relapsed or refractory forms of non-Hodgkin lymphoma (NHL), including large B-cell lymphoma (LBCL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, and follicular lymphoma (FL).<\/p>\n\n\n\n<p>The FDA&#8217;s decision is supported by Phase I data which demonstrated an overall response rate (ORR) of 83.1%, a complete response rate (CRR) of 72.3%, a median duration of response of 15.7 months, and a progression-free survival (PFS) of 15.3 months.- <a href=\"https:\/\/flcube.com\">Flcube.com<\/a><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY)&#8230;<\/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":[429,428,16,21,849,15],"class_list":["post-3343","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-bms","tag-bristol-myers-squibb","tag-cancer","tag-car-t","tag-nyse-bmy","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>FDA Extends Indication for BMS&#039; CAR-T Therapy Breyanzi to Include Relapsed MCL in Adults - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its CAR-T therapy Breyanzi (lisocabtagene maraleucel). 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