FDA Grants Full Approval to Brexucabtagene Autoleucel for Relapsed/Refractory Mantle Cell Lymphoma

The FDA has converted the accelerated approval of brexucabtagene autoleucel (brexu-cel; Tecartus) to a full approval for adult patients with relapsed or refractory mantle cell lymphoma (MCL). The decision, announced by Gilead — the drug’s developer — follows confirmatory data from the phase 2 ZUMA-2 trial (NCT02601313), demonstrating high response rates and a safety profile consistent with earlier clinical evaluations.

“The full approval of brexucabtagene autoleucel for adults with relapsed/refractory MCL reflects meaningful progress,” Gallia Levy, MD, PhD, senior vice president and global head of development at Kite, stated in a news release. “For those whose cancer has returned, the data support [the agent] as a second-line treatment option with the potential to deliver long-term remission.”

ZUMA-2 Efficacy: High Response Rates in Pretreated Populations

The regulatory conversion was supported by data across multiple patient cohorts from ZUMA-2, including those who were heavily pretreated. In cohort 3, which included patients who received up to 5 prior lines of therapy and were naive to TKIs, the objective response rate (ORR) reached 91%. Notably, 79% of these patients achieved a complete response (CR). After a median follow-up of 23.0 months, the median duration of response (DOR) in this cohort had not yet been reached.

Significant activity was also maintained in cohort 1, which consisted of patients previously treated with a BTK inhibitor. In this group, the ORR was 87% with a CR rate of 62%. After a median follow-up of 8.6 months, the median DOR was also not reached for these patients.

Managing CRS and Neurological Events

While brexu-cel offers the potential for long-term remission, the high incidence of treatment-specific toxicities requires intensive nursing monitoring and rapid intervention. Pooled safety data from cohorts 1 through 3 highlighted several key areas for clinical focus:

Cytokine Release Syndrome (CRS)

CRS was reported in 93% of the total patient population. While most cases were low-grade, 12% of patients experienced grade 3 or higher events.

• Median Onset: 4 days post-infusion.
• Median Duration: 7 days.

Neurological Toxicities

Neurological events—often referred to as immune effector cell-associated neurotoxicity syndrome (ICANS)—occurred in 80% of patients, with 33% experiencing grade 3 or higher events.

• Median Onset: 6 days post-infusion.
• Median Duration: 19 days.
• Clinical Presentations: Common severe symptoms included encephalopathy, aphasia, and motor dysfunction.

Infection and Other Adverse Effects

Infections were reported in 63% of patients (33% were grade 3 or higher). Additionally, severe non-ventricular arrhythmias, tachycardias, pyrexia, and musculoskeletal pain, which were among the common severe adverse effects noted in the trial, should be closely monitored.

Reference

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://tinyurl.com/yfkjyrh3