December 8, 2025 Category: FDA News / Cell Therapy and Hematology
Hello everyone! Today we close our round of updates with much-anticipated news in the field of regenerative medicine and cancer treatment. The FDA has approved an innovative CAR-T therapy for a group of patients who often have limited options.
On December 4, 2025, the agency gave the green light to lisocabtagene maraleucel (marketed as Breyanzi, by Bristol-Myers Squibb) to treat adults with marginal zone lymphoma (MZL).
Who is this treatment for?
This approval is specifically directed at patients with relapsed or refractory marginal zone lymphoma.
To be eligible, patients must have received at least two prior lines of systemic therapy. This includes those whose disease has returned after standard treatments or even after a stem cell transplant.
What do the data say? The TRANSCEND Study
The FDA's decision was based on results from the clinical trial TRANSCEND FL-MZL. In this study, researchers evaluated the efficacy of a single dose of Breyanzi after conditioning chemotherapy.
The numbers are encouraging for a population with hard-to-treat diseases:
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Overall Response Rate (ORR): An impressive 84.4% of patients responded to treatment.
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Complete Response (CR): More than half of patients (55.8%) achieved complete remission, meaning no signs of cancer were detected after treatment.
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Duration: The median duration of response has not yet been reached, suggesting that for many patients, the benefit is long-lasting.
Important Safety Information
Breyanzi is a potent therapy that uses the patient's own genetically modified T cells. As such, it carries specific risks that must be monitored in specialized centers:
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Serious Side Effects: These include Cytokine Release Syndrome (CRS) and neurological toxicities.
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Other Risks: Serious infections, low blood cell counts (cytopenias), and hypersensitivity reactions.
Due to these risks, the FDA recommends that patients be monitored closely to detect and treat any complications quickly.
The Impact
Marginal zone lymphoma is a slow-growing cancer but one that tends to return. Having access to a CAR-T therapy offers real hope for deep and lasting remission for patients who had already exhausted traditional chemotherapy pathways.
With information from FDA
What's Next?
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