On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company) for adults suffering from relapsed or refractory marginal zone lymphoma (MZL) who have undergone at least two prior lines of systemic therapy. This approval marks a significant advancement in the treatment landscape for MZL, a subtype of non-Hodgkin lymphoma that has historically presented limited therapeutic options for patients facing relapse.
The approval of Breyanzi is particularly noteworthy as it underscores the increasing focus on CAR T-cell therapies within oncology, especially for hematological malignancies. As the FDA continues to embrace innovative treatment modalities, the implications for pharmaceutical companies are profound. Firms engaged in CMC, regulatory affairs, and QA/QC must now adapt to the evolving landscape of cell and gene therapies, ensuring compliance and quality in the face of rapid advancements.
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