brexucabtagene autoleucel — Drug Monograph

Brand names: Tecartus

Drug class: Other

Mechanism of Action

Brexucabtagene autoleucel (brexu-cel, KTE-X19) is an autologous CD19-directed CAR-T cell therapy derived from the same KymRAH/Yescarta CAR construct platform (FMC63 anti-CD19 scFv, CD28 costimulatory domain, CD3ζ) but manufactured via a modified process specifically designed to deplete malignant circulating B cells from the leukapheresis product prior to T-cell transduction — addressing the challenge of CD19-positive contamination in B-cell malignancies with high circulating tumor burden (e.g., MCL and ALL in adults). Infused CAR-T cells bind CD19 on malignant B cells and mantle cell…

FDA Indications

• Relapsed or refractory mantle cell lymphoma (MCL) in adults (FDA approved July 24, 2020; based on ZUMA-2: 87% ORR, 62% CR)
• Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults (FDA approved October 2021; based on ZUMA-3: 71% CR rate)

Common Side Effects

• CRS (any grade >90%)
• Pyrexia
• Hypotension
• Tachycardia
• Confusion/encephalopathy
• Fatigue
• Nausea
• Febrile neutropenia
• Infection
• Headache

Clinical Pearl

Brexu-cel is the first and only CAR-T approved for adult B-ALL and the only CAR-T for MCL. Its unique manufacturing step — depletion of CD19+ malignant B cells from the apheresis product before transduction — distinguishes it from axi-cel and is specifically designed to reduce the risk of transducing malignant cells and generating a product with reduced T-cell purity. This makes it suitable for patients with high circulating MCL or blast-phase ALL.

Related Therapies & Mechanisms

• Moxetumomab pasudotox-tdfk (Lumoxiti) — Other · Leukemia
• Tisagenlecleucel (Kymriah) — Other · Leukemia
• Acalabrutinib (Calquence) — Lymphoma
• Bendamustine (Treanda) — Lymphoma