Dr. Skarbnik on the Approval of Brexucabtagene Autoleucel in MCL

Alan P. Z. Skarbnik, MD, a hematologist/oncologist with Novant Health, discusses the approval of brexucabtagene autoleucel (Tecartus) in ​relapsed/refractory mantle cell lymphoma (MCL).

On July 24, 2020, the FDA approved the CAR T-cell therapy brexucabtagene autoleucel for patients with ​relapsed/refractory MCL based on findings from the ​phase 2 ZUMA-2 study, says Skarbnik.

The ZUMA-2 trial evaluated brexucabtagene autoleucel in patients with relapsed/refractory MCL who previously received a BTK inhibitor​, Skarbnik says. Notably, the CAR T-cell product induced an 87% objective response rate and a 62% complete response rate in this patient population. 

​However, the regulatory decision does not require ​patients to have had prior exposure to a BTK inhibitor, ​explains Skarbnik.

Although BTK inhibitors offer an effective therapy for patients with relapsed/refractory MCL, the majority of responses do not exceed 26 months, Skarbnik explains.

As such, ​the decision to approve brexucabtagene autoleucel for all patients with relapsed/refractory MCL may allow more patients to derive extended responses, concludes Skarbnik.