FDA Approval Insights: Brexu-Cel for Relapsed/Refractory MCL: With Luhua (Michael) Wang, MD

In today’s episode, we welcomed Luhua (Michael) Wang, MD, to discuss the implications of the full FDA approval of brexucabtagene autoleucel (Tecartus; brexu-cel) for the treatment of adult patients with relapsed/refractory mantle cell lymphoma (MCL). Dr Wang is a professor in the Department of Lymphoma/Myeloma in the Division of Cancer Medicine, as well as a professor in the Department of Stem Cell Transplantation at The University of Texas MD Anderson Cancer Center in Houston.

On April 2, 2026, the FDA granted traditional approval to brexu-cel based on data from the phase 2 ZUMA-2 trial (cohorts 1 and 2, NCT02601313; cohort 3, NCT04880434), with confirmatory data from cohort 3 showing that patients naive to a BTK inhibitor experienced an overall response rate (ORR) of 91% (95% CI, 82.5%-95.9%), a complete response (CR) rate of 79% (95% CI, 69.0%-87.1%), and a median duration of response (DOR) that was not reached (NR; 95% CI, 26.2 months-not evaluable).

Dr Wang detailed the evolution of therapies in the MCL treatment paradigm, leading up to the approval of brexu-cel and the integration of CAR T-cell therapy. Along with highlighting the evolution of MCL management, Dr Wang explained how data from cohort 3 of ZUMA-2 add further context to the role of CAR T-cell therapy in the treatment paradigm and how it may affect treatment sequencing considerations.