{"id":9974,"date":"2024-01-10T00:25:00","date_gmt":"2024-01-09T16:25:00","guid":{"rendered":"https:\/\/flcube.com\/?p=9974"},"modified":"2024-11-13T23:08:56","modified_gmt":"2024-11-13T15:08:56","slug":"international-society-for-cell-gene-therapy-comments-on-fdas-car-t-investigation","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=9974","title":{"rendered":"International Society for Cell & Gene Therapy Comments on FDA’s CAR-T Investigation"},"content":{"rendered":"\n

The International Society for Cell & Gene Therapy (ISCT) has published a statement addressing the US Food & Drug Administration’s (FDA) investigation into a potential link between T-cell malignancies and CAR-T cell therapies. The FDA launched the inquiry in November following 20 reported cases of patients developing these malignancies after receiving BCMA- or CD19-directed autologous CAR-T cell therapies.<\/p>\n\n\n\n

The FDA’s warning encompasses all related products currently on the market, including Bristol Myers Squibb\u2019s (BMS; NYSE: BMY<\/a>) Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Johnson & Johnson\u2019s (J&J; NYSE: JNJ<\/a>) Carvykti (ciltacabtagene autoleucel), Novartis\u2019s (SWX: NOVN<\/a>) Kymriah (tisagenlecleucel), and Gilead\u2019s (NASDAQ: GILD<\/a>) Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel).<\/p>\n\n\n\n

The ISCT’s global group responded by noting that the reported incidence of T-cell malignancies is lower than that associated with conventional treatments. They emphasized that the available data is not sufficient to fully assess the risk of CAR-T therapies, while also highlighting that the benefits of these therapies currently outweigh the potential risks.- Flcube.com<\/a><\/p>\n\n\n\n

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The International Society for Cell & Gene Therapy (ISCT) has published a statement addressing the…<\/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],"tags":[429,428,16,21,226,150,149,1025,140,849,858,865,983],"class_list":["post-9974","post","type-post","status-publish","format-standard","hentry","category-company","tag-bms","tag-bristol-myers-squibb","tag-cancer","tag-car-t","tag-gilead-sciences","tag-jj","tag-johnson-johnson","tag-nasdaq-gild","tag-novartis","tag-nyse-bmy","tag-nyse-jnj","tag-nyse-nvs","tag-swx-novn"],"yoast_head":"\nInternational Society for Cell & Gene Therapy Comments on FDA's CAR-T Investigation - Insight, China's Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"The International Society for Cell & Gene Therapy (ISCT) has published a statement addressing the US Food & Drug Administration's (FDA) investigation into a potential link between T-cell malignancies and CAR-T cell therapies. 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