BMS files BLA at FDA for liso-cel to treat large B-cell lymphoma .
Bristol-Myers Squibb Company announced the submission of its Biologics License Application (BLA) to the FDA for lisocabtagene maraleucel (liso-cel), its autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy comprising individually formulated CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after at least two prior therapies.
The submission is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, evaluating liso-cel in 269 patients with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL). Bristol-Myers Squibb recently presented data from this pivotal study at the American Society of Hematology annual meeting.
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