Bristol Myers Squibb announced U.S. approval expanding its CAR-T therapy Breyanzi to include third-line treatment for marginal zone lymphoma, a rare indolent non-Hodgkin lymphoma. The approval makes Breyanzi the first CAR-T therapy cleared for this specific lymphoma subtype. The label expansion follows submission of clinical data supporting durable responses in previously treated patients. The decision expands the commercial footprint of Breyanzi into a new, lower-incidence indication while highlighting continued demand for engineered-cell therapies in hematologic cancers. Payers and treatment centers will now need to adapt referral and infusion workflows to accommodate a broader set of lymphoma patients eligible for outpatient or inpatient CAR-T administration.
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