Bristol Myers Squibb Expands Breyanzi Approval for Marginal Zone Lymphoma Treatment

bridge_anxiety · 2025-12-26T01:21:07+00:00

Bristol Myers Squibb's Breyanzi has received FDA approval for use in treating relapsed or refractory marginal zone lymphoma, demonstrating a 95.5% overall response rate in trials. This makes it the first CD19-directed CAR T cell therapy approved for five different cancers, indicating strong market potential.

bridge_anxiety

2025-12-26 01:21:07

Abstract generation in progress

Bristol Myers Squibb (BMY) has secured FDA clearance to extend Breyanzi’s therapeutic reach into the marginal zone lymphoma (MZL) market. The approval permits use of this CD19-directed CAR T cell therapy in adult patients with relapsed or refractory MZL who have exhausted at least two prior systemic treatment regimens.

Clinical Data Drives Approval Decision

The regulatory decision rests on compelling efficacy data from the MZL cohort within TRANSCEND FL, a phase 2 clinical trial investigating Breyanzi’s performance across multiple indolent B-cell non-Hodgkin lymphoma subtypes. For patients battling relapsed or refractory marginal zone lymphoma specifically, the drug demonstrated substantial clinical activity:

Overall response rate hit 95.5% in MZL patients
Complete response rate reached 62.1%
Durable disease control maintained through 24-month assessment in 88.6% of responders

These metrics underscore Breyanzi’s potency in attacking this previously challenging disease segment. Marginal zone lymphoma accounts for approximately 7% of all NHL cases, with typical diagnosis occurring around age 67.

Reshaping the CAR T Landscape

This latest indication makes Breyanzi the sole CD19-directed CAR T cell therapy approved across five distinct malignancy categories—follicular lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, large B-cell lymphoma, and now marginal zone lymphoma. The subcutaneous administration route provides practical advantages over intravenous alternatives.

Financial performance reflects market strength. Breyanzi generated $747 million in global revenue for 2024, with sales reaching $966 million during the first three quarters of 2025. BMY closed trading Thursday at $51.95, up 1.94%, reflecting investor optimism about the expanded commercial opportunity in marginal zone lymphoma treatment.

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