Trials & Filings

FDA Approves BMS CAR-T Cell Therapy

Breyanzi is a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of relapsed or refractory large B-cell lymphoma.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Bristol Myers Squibb received approval from the FDA for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. The approval is based on data from the TRANSCEND NHL trial in which 268 patients with R/R LBCL received Breyanzi. In the study, 192 patients were treated with Breyanzi at the dose of 50 to 110 x 106 CAR-posi...

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