FDA Grants Full Approval to Tecartus for Relapsed Mantle Cell Lymphoma

The U.S. Food and Drug Administration (FDA) has granted traditional full approval to the CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL) to provide a definitive second-line treatment option.

The decision, announced in a news release from Gilead, converts the previous accelerated approval from 2020 into a full approval for patients whose cancer has returned or has not responded to previous treatments. This regulatory milestone is intended to verify the clinical benefit of the therapy for patients who have received at least one prior line of therapy, including those who have not yet been treated with a Bruton tyrosine kinase inhibitor (BTKi).

Main data that support the findings

The FDA decision was based on the totality of evidence from the ZUMA-2 study, which included newly integrated data from Cohort 3. This specific group consisted of patients with relapsed or refractory mantle cell lymphoma who were BTKi-naïve.

In cohort 3, the objective response rate (ORR) was 91%, with 79% of patients achieving a complete remission, meaning no signs of cancer were detectable. These results were compared with cohorts 1 and 2, which involved patients previously treated with a BTKi. In those cohorts, the ORR was 87% and the complete remission rate was 62%.

Durability of the treatment was a key highlight of the findings. For both the BTKi-exposed and BTKi-naïve groups, the median duration of response had not yet been reached at the time of the analysis. The median follow-up time for the duration of response was 8.6 months for cohort 1 and 23 months for cohort 3.

Trial details

ZUMA-2 is a multicenter, open-label, single-arm study designed to evaluate the efficacy and safety of Tecartus in adults with mantle cell lymphoma. The trial enrolled different groups of patients based on their prior treatment history to ensure a broad understanding of how the therapy performs at various stages of the disease.

Cohorts 1 and 2 included a total of 82 treated patients who had undergone up to five previous lines of therapy. These previous treatments included an anti-CD20 antibody, a BTKi and chemotherapy containing either anthracycline or bendamustine. These patients had a median of three prior therapies.

Cohort 3 included 86 treated patients who had also received up to five prior lines of therapy but had never been treated with a BTKi. The patients in this group had a median of one prior therapy. The primary goal for all cohorts was to measure the objective response rate. The study also monitored pharmacokinetics and the long-term safety profile of the therapy.

Mantle cell lymphoma is an aggressive and rare form of non-Hodgkin lymphoma that begins in the "mantle zone" of the lymph node. It primarily affects men over age 60, with approximately 33,000 global diagnoses annually. Because the disease often progresses quickly after a relapse, the trial focused on those with limited remaining treatment options.

Safety

Safety data for the treatment was pooled from 168 patients across all three cohorts of the ZUMA-2 study. The therapy carries a boxed warning for cytokine release syndrome (CRS), neurologic toxicities and secondary hematological malignancies.

In the pooled group, CRS occurred in 93% of patients, with 12% experiencing grade 3 (severe) or higher events. The median time for CRS to begin was four days after infusion, lasting for a median of seven days. One patient died following a fatal CRS event.

Neurologic events were reported in 80% of patients, and 33% experienced grade 3 or higher events. These events began at a median of six days and lasted for a median of 19 days. While 82% of these neurologic events resolved, eight patients had ongoing events at the time of death.

Other safety findings included:

• Infections: 63% of patients experienced infections of any grade, with 33% experiencing grade 3 or higher.
• Serious Adverse Reactions: In cohort 3, 65% of patients had serious adverse reactions, including fever, pneumonia, and various bacterial, viral or fungal infections.
• Prolonged Cytopenias: 55% of patients had low blood cell counts that did not resolve by Day 30.
• Hypogammaglobulinemia: 14% of patients experienced a decrease in antibodies in the blood.

Common side effects occurring in at least 20% of patients included fatigue, cough, nausea, headache, muscle pain, and decreased appetite. Patients are advised to avoid driving for at least two weeks following treatment and must be monitored for secondary malignancies for the rest of their lives

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

References

1. “U.S. FDA Grants Full Approval of Kite’s Tecartus® for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma.” News release. Gilead. April 2, 2026.

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