S17 Ep23: FDA Approval Insights: Brexu-Cel for Relapsed/Refractory MCL: With Luhua (Michael) Wang, MD

About this episode

Dr. Luhua (Michael) Wang discusses the FDA approval of brexucabtagene autoleucel for relapsed/refractory mantle cell lymphoma and its implications in treatment paradigms.

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…

People in this episode

Guest: Luhua (Michael) Wang, MD

Topics covered

• FDA approval
• brexucabtagene autoleucel
• mantle cell lymphoma
• CAR T-cell therapy
• ZUMA-2 trial
• treatment paradigm

Keywords

• brexucabtagene autoleucel
• FDA approval
• mantle cell lymphoma
• CAR T-cell therapy
• ZUMA-2 trial
• treatment sequencing
• overall response rate
• complete response rate
• duration of response

Mentioned in this episode

Organizations: The University of Texas MD Anderson Cancer Center

Products: brexucabtagene autoleucel, Tecartus

Places: Houston

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