Posted by Michael Wonder on 06 Feb 2021
FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma
5 February 2021 - Today, the FDA approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified (including relapsed or refractory arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
Efficacy was evaluated in TRANSCEND, a single-arm, open label, multicenter trial that evaluated lisocabtagene maraleucel, preceded by lymphodepleting chemotherapy, in adults with relapsed or refractory large B-cell lymphoma after at least two lines of therapy.
