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FDA Approves Breyanzi: Breakthrough CAR T-Cell Therapy for MZL

12/6/2025

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Summary

Story summary

The U.S. Food and Drug Administration (FDA) approved Breyanzi (Lisocabtagene maraleucel) as the first CAR T-cell therapy for adults with marginal zone lymphoma (MZL) after two or more prior treatments.
In clinical trials, Breyanzi produced a 95.5% response rate and a 62.1% complete remission rate.
Common side effects include cytokine release syndrome and fatigue.
Bristol Myers Squibb aims to compete with Gilead's CAR-T therapies, which have seen declining sales.

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Story summary

The U.S. Food and Drug Administration (FDA) approved Breyanzi (Lisocabtagene maraleucel) as the first CAR T-cell therapy for adults with marginal zone lymphoma (MZL) after two or more prior treatments.
In clinical trials, Breyanzi produced a 95.5% response rate and a 62.1% complete remission rate.
Common side effects include cytokine release syndrome and fatigue.
Bristol Myers Squibb aims to compete with Gilead's CAR-T therapies, which have seen declining sales.