FDA Approval

Tecartus (brexucabtagene autoleucel) Receives FDA Approval for Relapsed or Refractory Mantle Cell Lymphoma

Edited by:
Anthony Calabro, MA

Key Highlights

  • The FDA granted full approval to Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
  • Data from the ZUMA-2 study, a single-arm, open-label, multicenter trial, supported the approval.
  • Objective response rates were 87% in Bruton tyrosine kinase inhibitor–exposed patients and 91% in BTKi-naïve patients.
  • The prescribing information includes boxed warnings for cytokine release syndrome; neurologic toxicities, including immune effector cell–associated neurotoxicity syndrome; and secondary malignancies.

On April 2, 2026, the FDA granted traditional (full) approval to Tecartus (brexucabtagene autoleucel) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). The indication includes patients who have received 1 or more prior lines of therapy, including those who are Bruton tyrosine kinase inhibitor (BTKi)–naïve. This action converts the prior accelerated approval to full approval based on confirmatory evidence. Brexucabtagene autoleucel is a CD19-directed genetically modified autologous T-cell immunotherapy.

The approval is supported by data from ZUMA-2, a single-arm, open-label, multicenter study evaluating brexucabtagene autoleucel in adults with relapsed or refractory MCL. Cohorts 1 and 2 included patients previously treated with up to 5 lines of therapy, including chemotherapy, an anti-CD20 antibody, and a BTKi, whereas Cohort 3 enrolled BTKi-naïve patients. The primary endpoint was an objective response rate assessed by an independent radiologic review committee per Lugano Classification (2014).

Among efficacy-evaluable patients, objective response rates were 87% in Cohort 1 and 91% in Cohort 3, with complete remission rates of 62% and 79%, respectively. Median duration of response was not reached in either cohort at the time of analysis, with median follow-up of 8.6 months in Cohort 1 and 23.0 months in Cohort 3.

“The Cohort 3 results showed high response rates, including deep remissions, in patients who were BTKi–naïve, with a manageable safety profile consistent with prior experience,” Michael Wang, MD, ZUMA-2 Lead Investigator and Professor, Department of Lymphoma and Myeloma, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, said in a press release.

Safety data pooled across 168 patients treated in ZUMA-2 showed cytokine release syndrome (CRS) in 93% of patients, including grade ≥3 CRS in 12%. Neurologic events occurred in 80% of patients, including grade ≥3 events in 33%, with immune effector cell–associated neurotoxicity syndrome (ICANS) among them. The median time to onset was 4 days for CRS and 6 days for neurologic events. Infections occurred in 63% of patients, including grade ≥3 infections in 33%.

Common serious adverse reactions included arrhythmias, infections, neurologic toxicities, hypotension, and thrombotic events. The prescribing information includes a boxed warning for CRS; neurologic toxicities, including ICANS; and secondary malignancies.

Reference
Gilead Sciences. U.S. FDA grants full approval of Kite’s Tecartus® for adult patients with relapsed or refractory mantle cell lymphoma. News release. April 2, 2026. Accessed April 15, 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