Bristol-Myers Squibb announces submission of biologics license application for CAR T-Cell therapy lisocabtagene maraleucel (liso-cel) to FDA

BMS

18 December 2019 - Submission includes data from TRANSCEND NHL 001 trial evaluating liso-cel in patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma.

Bristol-Myers Squibb Company today announced the submission of its biologics license application to the U.S. 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 large B-cell lymphoma after at least two prior therapies.

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Michael Wonder

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Michael Wonder

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Dossier , Cellular therapy , FDA