FDA Approves Brexucabtagene Autoleucel for Refractory Mantle Cell Lymphoma

The FDA has announced the full approval of brexucabtagene autoleucel (brexu-cel; Tecartus/Gilead Sciences, Inc) for use in adults diagnosed with relapsed or refractory (R/R) mantle cell lymphoma (MCL).¹ The April 2, 2026, approval is based on new data for patients with R/R MCL who are Bruton tyrosine kinase (BTK) inhibitor–naive and who have received at least 1 line of therapy.

The approval is based on the ZUMA-2 study (NCT02601313), which is a single-arm, open-label, multicenter study. Cohort 3 provided the basis for approval and focused on brexu-cel in patients who had received up to 5 lines of therapy while remaining naive to BTK inhibitors. Cohorts 1 and 2 had previously evaluated brexu-cel in patients who had received up to 5 lines of therapy and had also received a BTK inhibitor, an anti-CD20 antibody, and chemotherapy containing either an anthracycline or bendamustine.

Patients in cohort 3 met the following criteria: They had been treated with up to 5 prior regimens for MCL and had at least 1 measurable lesion, a platelet count of 75,000/uL or more, a cardiac ejection fraction of 50% or more, and a baseline oxygen saturation of more than 92% on room air. Any participant with a known history of HIV, hepatitis B, or hepatitis C; a history of seizure disorders, dementia, or any autoimmune disease that included the central nervous system; or the presence of any infection was excluded from the study.² Objective response rate (ORR) was the primary end point of the study.

There were 86 patients included in cohort 3. The ORR was 91%, the complete remission rate was 79%, and the median follow-up time was 23 months. Median duration of response was not reached during the trial period.

In the pooled MCL population, cytokine release syndrome (CRS) occurred in 93% of the patients, and 12% had grade 3 or higher CRS. A total of 80% of the patients experienced neurological events, and grade 3 or higher neurological events were experienced by 33%. Any grade of infection occurred in 63% of the patients, and 33% of the patients experienced an infection that was grade 3 or higher.

Sixty-five percent of cohort 3 experienced a serious adverse reaction, with the most common being nonventricular arrhythmias, pyrexia, tachycardias, viral infections, fungal infections, bacterial infections, CRS, unspecified pathogen infections, motor dysfunction, musculoskeletal pain, aphasia, tremor, delirium, seizure, encephalopathy, hyopia, hemorrhage, hypotension, and thrombosis.

MCL is a rare form of non-Hodgkin lymphoma, a blood cancer.³ There is currently no cure for the cancer that often goes through a cycle of remission and relapse. The cancer mostly affects men 60 years and older and affects approximately 33,000 people around the world who are diagnosed each year.¹ The cancer arises in the “mantle zone” of the lymph node, which lends its name.

“The Cohort 3 results showed high response rates, including deep remissions, in patients who were Bruton tyrosine kinase inhibitor–naïve, with a manageable safety profile consistent with prior experience. These data provide important information to help guide treatment decisions in the relapsed or refractory setting for appropriate patients,” Michael Wang, MD, the lead investigator of ZUMA-2 and a professor in the Department of Lymphoma and Myeloma in the Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center, said in a statement.¹

Brexu-cel was granted accelerated approval in 2020 to be used in patients with MCL based on the results of cohorts 1 and 2.⁴ These results found that 87% of the patients had responded to a single infusion of the treatment, and 62% had a complete response. Its approval marked the first chimeric antigen receptor (CAR) T-cell treatment for R/R MCL.

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. Accessed April 2, 2026. https://www.gilead.com/company/company-statements/2026/us-fda-grants-full-approval-of-kite-tecartus-for-adult-patients-with-relapsed-or-refractory-mantle-cell-lymphoma
2. Study of brexucabtagene autoleucel (KTE-X19) in participants with relapsed/refractory mantle cell lymphoma (Cohort 3) (ZUMA-2). Gilead. Updated November 17, 2025. Accessed April 2, 2026. https://www.gileadclinicaltrials.com/study?id=KTE-C19-102%20(Cohort%203)
3. Mantle cell lymphoma. Cleveland Clinic. Updated May 8, 2025. Accessed April 2, 2026. https://my.clevelandclinic.org/health/diseases/24030-mantle-cell-lymphoma
4. U.S. FDA approves Kite’s Tecartus, the first and only CAR T treatment for relapsed or refractory mantle cell lymphoma. News release. Gilead. July 24, 2020. Accessed April 2, 2026. https://www.gilead.com/news/news-details/2020/us-fda-approves-kites-tecartus-the-first-and-only-car-t-treatment-for-relapsed-or-refractory-mantle-cell-lymphoma