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U.S. Food and Drug Administration Approves Bristol Myers Squibb's Breyanzi , a New CAR T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma

Breyanzi demonstrated a 73% overall response rate and 54% complete response rate in the largest pivotal trial in 3L+ LBCL, TRANSCEND NHL 001 trial Breyanzi demonstrated sustained responses in patients who achieved a CR with median duration of response not reached G rade ≥3 cytokine release syndrome and Grade ≥3 neurologic toxicities following Breyanzi treatment occurred in 4% and 12% of patients, respectively . ....

District Of Columbia , United States , Meghan Gutierrez , Samit Hirawat , Bristol Myers Squibb , Kimberly Whitefield , Jeremy Abramson , Drug Administration , Bristol Myers Squibb Company , Exchange Commission , European Union , European Medicines Agency , Juno Therapeutics Inc , Lymphoma Research Foundation , American Cancer Society , Myers Squibb , Important Safety Information , Cytokine Release Syndrome , Neurologic Toxicities , Bristol Myers , Risk Evaluation , Mitigation Strategy , Cell Therapy , Massachusetts General Hospital , Lymphoma Research , Priority Medicines ,

U.S. Food and Drug Administration Approves Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel), a New CAR T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma


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05-Feb-2021
U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel), a New CAR T Cell Therapy for Adults with Relapsed or Refractory Large B-cell Lymphoma
  
Breyanzi
demonstrated a 73% overall response rate and 54% complete response (CR) rate in the largest pivotal trial in 3L+ LBCL, TRANSCEND NHL 001 trial
Breyanzi
G
treatment occurred in 4% and 12% of patients, respectively
PRINCETON, N.J. (BUSINESS WIRE) $BMY#BMS Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved
Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not oth ....

District Of Columbia , United States , Meghan Gutierrez , Samit Hirawat , Bristol Myers Squibb , Kimberly Whitefield , Jeremy Abramson , Drug Administration , Bristol Myers Squibb Company , Exchange Commission , European Union , European Medicines Agency , Juno Therapeutics Inc , Lymphoma Research Foundation , Important Safety Information , Cytokine Release Syndrome , Neurologic Toxicities , Bristol Myers , Myers Squibb , Risk Evaluation , Mitigation Strategy , Cell Therapy , Massachusetts General Hospital , Lymphoma Research , Priority Medicines , Marketing Authorization Application ,