FDA Approves Brexucabtagene Autoleucel in Adult R/R MCL

The FDA has granted full approval to brexucabtagene autoleucel (Tecartus) for the treatment of adult patients with relapsed/refractory mantle cell lymphoma (MCL), according to a news release from the developer, Gilead.

Forming the basis of the regulatory decision were results from the phase 2 ZUMA-2 trial (NCT02601313), which demonstrated high response rates and durable efficacy, as well as a manageable safety profile consistent with prior drug evaluation. This was also the case in Cohort 3 of the trial, which included patients who received up to 5 prior lines of therapy and were not previously treated with a tyrosine kinase inhibitor (TKI).

Efficacy data from patients treated in Cohort 3 showed an objective response rate (ORR) of 91%, with 79% experiencing a complete response (CR). Additionally, the median duration of response was not reached (NR) after a median follow-up of 23.0 months.

In Cohort 1, which included patients who received up to 5 lines of therapy and who were previously treated with a BTK inhibitor, the ORR and CR rate was 87% and 62%, respectively. After a median follow-up of 8.6 months, the median DOR was not reached.

“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 the release. “For those whose cancer has returned, the data support [brexucabtagene autoleucel] as a second-line treatment option with the potential to deliver long-term remission.”

The regulatory action converts an initial relapsed/refractory indication into a full approval, fulfilling post-marketing requirement for verification and description of clinical benefit with the agent, specifically within a confirmatory trial under the Accelerated Approval pathway.

The updated safety data pooled across Cohorts 1 to 3 showed a cytokine release syndrome (CRS) incidence of 93% across the entire patient population, including 12% experiencing grade 3 or higher events. The median time to onset was 4 days, and the median duration of events was 7 days. Any-grade or grade 3 or higher neurological events occurred in 80% and 33% of this group, with a median onset of 6 days and median duration of 19 days. Infections of any grade or grade 3 or higher occurred in 63% and 33% of patients.

Common severe adverse effects included non-ventricular arrhythmias, tachycardias, pyrexia, musculoskeletal pain, motor dysfunction, encephalopathy, and aphasia, among others.

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