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Breyanzi® (lisocabtagene maraleucel) – New orphan drug approval

February 5, 2021 - The FDA announced the approval of Bristol-Myers Squibb Breyanzi (lisocabtagene maraleucel), 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 (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

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