FDA continues its round of drug approvals as Bristol Myers Squibb announced the agency’s approval of Breyanzi, a CAR T cell therapy, for adults with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therpay.¹

The approval makes Breyanzi the only CAR T cell therapy to be approved by FDA for five cancer types, the most of any CD19-directed CAR T cell therapy.¹

Breyanzi, a CD19-directed CAR T cell therapy, holds a 4-1BB costimulatory domain, enhancing the expansion and persistence of CAR T cells. Breyanzi is created from a patient’s own T cells, which is then collected and genetically reengineered to become CAR T cells that get delivered via infusion as a one-time treatment.¹ The treatment process for Breyanzi includes blood collection, CAR T cell creation, potential bridging therapy, lymphodepletion, administration, and side-effect monitoring.¹

“The FDA approval of Breyanzi for relapsed or refractory marginal zone lymphoma further solidifies it as the leading CD19-directed CAR T cell therapy covering the broadest range of B-cell malignancies. This approval in a fifth cancer type reflects our bold vision to bring the transformational potential of cell therapy to more patients," said Lynelle B. Hoch, president of the Cell Therapy Organization at Bristol Myers Squibb. “Breyanzi is the first and only CAR T cell therapy approved for this patient population, demonstrating Bristol Myers Squibb’s deep commitment to expanding access and reaching as many patients as possible with this innovative, practice-changing treatment.”

What was FDA’s approval of Brevanzi based off?

The agency based its approval on results gathered from the MZL cohort in the Phase II Transcend FL, open-label, multicenter, multi-cohort, single-arm study.¹

The study’s results included a 95.5% overall response rate of patients treated with Breyanzi in the third line plus setting and is based on the U.S. Prescribing Information (USPI).¹ The study’s complete response rate was 62.1%, with the median duration of response not being reached with 90.1% of responders remaining in response at 24 months.¹

Additionally, Breyanzi’s safety profile in R/R MZL remained consistent with prior reports collected from trials in other indications. In the MZL cohort of the Transcend FL study, any grade cytokine release syndrome (CRS) occurred in 76% of patients, including Grade ≥3 CRS in 4.5% of patients.¹

Additional any grade nervous system disorders recorded includes:

• Headache (21%)
• Tremor (21%)
• Encephalopathy (21%)
• Dizziness (16%)
• Aphasia (10%)

“Patients living with marginal zone lymphoma, a subtype of indolent non-Hodgkin lymphoma, generally see success with initial therapy, but a subset of patients ultimately experience multiple relapses over the course of many years, creating a pressing need for new treatment options with durable outcomes,” said M. Lia Palomba, M.D., Transcend FL study investigator and lymphoma and cell therapy specialist, Memorial Sloan Kettering Cancer Center. “The FDA approval of liso-cel in relapsed or refractory marginal zone lymphoma is a significant advancement in redefining the treatment landscape and providing patients with an option that has demonstrated high rates of responses with an established safety profile.”

Sources

1. Bristol Myers Squibb’s Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL) Bristol Myers Squibb December 4, 2025 https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibbs-Breyanzi-Approved-by-the-U-S--FDA-as-the-First-and-Only-CAR-T-Cell-Therapy-for-Adults-with-Relapsed-or-Refractory-Marginal-Zone-Lymphoma-MZL/default.aspx