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hapabapa/iStock Editorial via Getty Images The U.S. FDA has approved Bristol-Myers Squibb's ( NYSE: BMY ) CAR-T therapy Breyanzi (lisocabtagene maraleucel) as a third-line treatment for mantle cell lymphoma.

In relapsed or refractory MCL, Breyanzi is given as a one-time infusion. Approval was based on the results of the MCL cohort of the TRANSCEND NHL 001 trial. These patients received at least two prior lines of therapy, including a BTK inhibitor.



Results showed 67.6% of patients achieved a complete response. Breyanzi is also approved for large B-cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, and follicular lymphoma.

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