Dr Gruenbaum on the Significance of the FDA Approval of Brexu-cel for MCL

“The high ORR and CR rates [shown with brexu-cel in MCL] that led to the approval are absolutely essential.”

Lore Gruenbaum, PhD, chief scientific officer and senior vice president of Research at Blood Cancer United, discussed the April 2026 FDA approval of brexucabtagene autoleucel (Tecartus; brexu-cel) for patients with relapsed or refractory mantle cell lymphoma (MCL), as well as the phase 2 ZUMA-2 trial (cohorts 1 and 2, NCT02601313; cohort 3, NCT04880434) data that supported the regulatory decision. Gruenbaum underscored the importance of the approval, as well as which areas of research she believes the MCL field should explore beyond CAR T-cell therapies like brexu-cel.

Data from the trial among evaluable patients in cohort 3 (n = 86) and cohort 1 (n = 60) supported the approval. In cohort 3, at a median follow-up of 23.0 months, efficacy-evaluable patients who received brexu-cel achieved an overall response rate (ORR) of 91% (95% CI, 82.5%-95.9%) in addition to 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 [NE]). Regarding cohort 1, at a median follow-up of 8.6 months, efficacy-evaluable patients reached an ORR of 87% (95% CI, 75%-94%), a CR rate of 62% (95% CI, 48%-74%), and a median DOR that was also NR (95% CI, 8.6 months-NE). Notably, patients in cohort 3 had received a median of 1 prior line of therapy (range, 1-5), whereas patients in cohort 1 had received a median of 3 prior lines of therapy (range, 2-5).

Gruenbaum mentioned that in MCL and other lymphoma treatment settings, it is important to have multiple approved options since patients each have comorbidities and living situations that make them more suitable to receive certain treatments. She added that CAR T-cell therapies like brexu-cel enable many patients to achieve long, lasting remissions. However, Gruenbaum also acknowledged that there are limitations regarding access to and eligibility for CAR T-cell therapy. Ultimately, however, Gruenbaum emphasized the promise of the response data shown with brexu-cel in MCL.

Gruenbaum then moved into a conversation about treatment sequencing following CAR T-cell therapy. She pointed out bispecific antibodies as a potential viable treatment option for patients with MCL who relapse following CAR T-cell therapies like brexu-cel. Now that brexu-cel is approved in the MCL treatment arena, Gruenbaum honed in on optimal treatment sequencing as an area that the MCL field should explore next.