Supplemental biologics license application submitted for brexucabtagene autoleucel for use in R/R B-cell ALL

Relapsed or refractory (R/R) acute lymphoblastic lymphoma (ALL) is associated with poor prognosis and short overall survival. B-cell ALL is the most common type, accounting for approximately 75% of cases in adults with ALL. Brexucabtagene autoleucel is a CD19-directed, genetically modified, autologous chimeric antigen receptor (CAR) therapy that was granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with B-cell ALL in 2017, and now a supplemental biologics license application has been submitted to the FDA.¹

The submission is based on the ongoing phase I/II ZUMA-3 trial (NCT02614066) investigating the safety and efficacy of brexucabtagene autoleucel in adult patients with ALL who are refractory to or relapse after standard systemic therapy or hematopoietic stem cell transplantation. If approved, this would be the first licensed CAR T-cell therapy in this patient population.

Brexucabtagene autoleucel has been approved by the FDA in 2020 for R/R mantle cell lymphoma, and it is currently being investigated for the treatment of patients with chronic lymphoblastic lymphoma (CLL) and pediatric ALL.