Dr Wang on the Full FDA Approval of Brexu-Cel in R/R Mantle Cell Lymphoma

If you put [patients from] cohort 1, cohort 2, and cohort 3 all together…the ORR is still very high and CR [rate] was very high.

Luhua (Michael) Wang, MD, a professor in the Department of Lymphoma/Myeloma of the Division of Cancer Medicine and the Department of Stem Cell Transplantation at The University of Texas MD Anderson Cancer Center, discussed the significance of the full FDA approval of brexucabtagene autoleucel (brexu-cel; Tecartus) for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL).

On April 2, 2026, the FDA granted traditional approval to brexu-celfor the treatment of adult patients with relapsed/refractory MCL, based on data from phase 2 ZUMA-2 trial (cohorts 1 and 2, NCT02601313; cohort 3, NCT04880434). Confirmatory findings from cohort 3, which included patients with relapsed/refractory disease following at least 1 line of therapy who had not previously received a BTK inhibitor (n = 86) showed that at a median follow-up of 23.0 months, the overall response rate (ORR) was 91%, including a complete response (CR) rate of 79%. The median duration of response (DOR) was not reached.

The traditional approval followed the FDA’s June 2020 accelerated approval of brexu-cel for the treatment for adult patients with relapsed/refractory MCL, which was supported by data from cohorts 1 and 2 of ZUMA-2.

Wang emphasized the importance of the expanded dataset, which includes outcomes for patients in cohort 3 who were naive to a BTK inhibitor prior to receiving brexu-cel. The similarly strong outcomes reported in the BTK inhibitor–exposed and ­–naive populations strengthened the overall evidence base supporting the use of brexu-cel in the relapsed/refractory setting, Wang explained.

Importantly, he framed the safety profile as manageable and in line with expectations for CAR T-cell therapy, without new concerns emerging over time.

With long-term follow-up data available from earlier cohorts of ZUMA-2 and the additional data from cohort 3, Wang concluded that the totality of data for brexu-cel underscore its ability to drive durable remissions and survival in this patient population.