Bristol-Myers Squibb Co. (BMY) has sought FDA approval to expand the use of Breyanzi as a treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy, and a decision is expected on December 5, 2025.Marginal zone lymphoma is the third most common lymphoma, accounting for about 7% of all non-Hodgkin lymphoma cases. While initial therapy for marginal zone lymphoma can be effective, multiple relapses over the course of several years are common, leaving patients in need of a new treatment option that can provide high, lasting response rates, according to the company.In a phase 2 trial, dubbed TRANSCEND FL, 95.5% of patients with relapsed or refractory marginal zone lymphoma (MZL) treated with Breyanzi responded to the treatment, with 62.1% achieving a complete response and 88.6% maintaining a response at 24 months.Breyanzi, a CD19-directed CAR T cell therapy administered subcutaneously, is already approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, follicular lymphoma, and mantle cell lymphoma. The drug generated global sales of $359 million in the third quarter of 2025, an increase of 60% over the year-ago comparable quarter.BMY closed Wednesday’s (November 26, 2025) trading at $49.25, up 0.41%.