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

Welcome to OncLive On Air^®! I'm your host today, Ashling Wahner.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s video 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.

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