The U.S. Food and Drug Administration approved Breyanzi for adults with relapsed or refractory marginal zone lymphoma who have already tried at least two prior systemic therapies. This approval expands the list of cancers for which Breyanzi is authorized and gives patients a new option when other treatments have failed.
In plain language: what is Breyanzi?
Breyanzi is a CAR‑T cell therapy – doctors take a patient’s own T cells, reprogram them in a lab to recognize a protein called CD19 on certain lymphoma cells, grow billions of those engineered cells, then infuse them back into the patient so they can hunt down and kill the cancer. Think of it as training a patient’s immune system to be a targeted cancer-fighting squad.
How well does it work?
Different ways of counting responses were reported in the studies:
- In the intention‑to‑treat analysis, the overall response rate (ORR) was about 84%, with a complete response (CR) rate near 56%.
- In the treated/evaluable group reported by the company, the ORR was 95.5% and CR 62.1% – numbers that show deep responses in many patients who received the product as intended.
Both sets of numbers are encouraging because they show many patients’ tumors shrank or became undetectable after a single infusion, and many responses were durable over time.
Safety – what to watch for
Breyanzi can cause serious side effects, the most important being cytokine release syndrome (CRS) and neurologic toxicities (confusion, seizures, etc.). Other risks include infections, low blood counts, and immune system changes that can make infections more likely. These risks mean treatment is done at specialized centers with experience managing CAR‑T side effects.
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Quick facts
| What it means | Key number | |
| Type | CAR‑T cell therapy | One‑time infusion |
| Approval use | Adults with relapsed/refractory MZL after ≥2 therapies | FDA approved Dec 2025 |
| Main risks | Immune reaction and neurologic effects | CRS and neurotoxicity possible |
Why this matters
For people with MZL who have run out of standard options, Breyanzi offers a potentially powerful, single‑treatment approach that can produce deep remissions. But it’s not a simple pill – it’s complex, requires specialized care, and carries serious risks that need close monitoring.
Next steps if you or a loved one are interested
- Talk to a lymphoma specialist about eligibility and what to expect.
- Ask whether the treatment center has CAR‑T experience and how they handle CRS and neurologic events.
- Check insurance coverage and patient support programs; manufacturers often offer help navigating access and logistics.
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References (3)
- FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma
- FDA Approves First CAR T-Cell Therapy for Marginal Zone Lymphoma In the US https://www.fda.gov/news-events/press-announcements/fda-approves-first-car-t-cell-therapy-marginal-zone-lymphoma-us
- 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) 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