The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has issued a positive opinion for brexucabtagene autoleucel for the treatment of adults aged 26 years and older with relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).
Brexucabtagene autoleucel is a CD19-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell immunotherapy that was previously approved for the treatment of adults with relapsed or refractory mantle cell lymphoma. If approved for ALL, brexucabtagene autoleucel will be the first and only CAR T-cell therapy for this population of patients who currently have limited treatment options.
The EMA’s opinion is based on results from the international, multicenter, single-arm, open-label, registrational, phase I/II ZUMA-3 study of adults with R/R ALL. The study found that 71% of evaluable patients (n=55) achieved complete remission (CR) or CR with incomplete hematological recovery (CRi) after a median follow-up of 26.8 months.
In an extended dataset of all patients who received the pivotal dose (n=78), the median overall survival for all patients was 25.4 months and 47.0 months for responders (patients who achieved CR or CRi). Among efficacy-evaluable patients, median duration of remission was 18.6 months.
Source: BusinessWire via Kite, July 2022