Brexucabtagene Autoleucel (Tecartus®): A Comprehensive Monograph on a CD19-Directed CAR T-Cell Immunotherapy

Executive Summary & Introduction: A Paradigm Shift in Hematologic Malignancies

Brexucabtagene autoleucel, marketed under the brand name Tecartus®, is a highly specialized, autologous, CD19-directed chimeric antigen receptor (CAR) T-cell immunotherapy.[1] As a cell-based gene therapy, it represents a significant departure from traditional chemotherapy and small molecule inhibitors, harnessing the patient's own immune system to combat cancer.[3] The therapy is classified as a miscellaneous antineoplastic agent and is manufactured by Kite, a Gilead Company.[5]

This therapy was developed to address a profound unmet clinical need in two distinct and aggressive hematologic malignancies: relapsed or refractory (R/R) Mantle Cell Lymphoma (MCL) and R/R B-cell precursor Acute Lymphoblastic Leukemia (ALL) in adults.[1] MCL is a rare and aggressive form of B-cell non-Hodgkin's lymphoma, where patients who relapse after multiple lines of therapy, including Bruton's tyrosine kinase (BTK) inhibitors, have historically faced a dismal prognosis with limited effective treatment options.[3] Similarly, adult R/R B-cell precursor ALL is a challenging disease with low remission rates and poor long-term survival with conventional salvage chemotherapy.[9] Brexucabtagene autoleucel was the first CAR T-cell therapy to gain approval for both of these specific, heavily pre-treated patient populations, marking a pivotal advancement in the field.[3]