FDA Approves Bristol Myers' Breyanzi For Relapsed/Refractory Marginal Zone Lymphoma

(RTTNews) - Bristol Myers Squibb (BMY) today announced that the FDA has expanded Breyanzi's approval to include treatment of relapsed or refractory (R/R) marginal zone lymphoma in adult patients who have received at least two prior lines of systemic therapy.

The approval was based on results from MZL cohort of TRANSCEND FL, a phase 2 single-arm study that evaluated the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma.

According to the study findings, 95.5% of patients with relapsed or refractory marginal zone lymphoma (MZL) treated with Breyanzi achieved a response, with 62.1% achieving a complete response and 88.6% maintaining a response at 24 months.

Marginal zone lymphoma (MZL) is a subtype of non-Hodgkin lymphoma (NHL), accounting for about 7% of all NHL cases. Most patients with MZL are diagnosed at a median age of 67 years.

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.

With the latest approval, Breyanzi becomes the only CAR T cell therapy approved by the FDA for five different cancer types, the most of any CD19-directed CAR T cell therapy.

The drug generated global sales of $747 million for the full year of 2024 and $966 million in the first nine months of 2025.

BMY shares closed Thursday's trade at $51.95 ,up 1.94%.