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Bristol-Myers Squibb has submitted a biologics license application to the FDA seeking approval of the anti-CD19 CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma after at least 2 prior therapies.

Early results from a prospective postmarketing assessment showed that tisagenlecleucel induced responses similar to those seen in pivotal trials for children and adolescents with B-cell acute lymphoblastic leukemia and adults with diffuse large B-cell lymphoma.