Drug Profile

Brexucabtagene autoleucel - Kite Pharma

Alternative Names: Autologous anti-CD19-transduced CD3+ cells; Brexu-cel; Brexucabtageneautoleucel; KTE-X19; Tecartus

Latest Information Update: 18 Mar 2025

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At a glance

Originator Cabaret Biotech
Developer Kite Pharma
Class Antineoplastics; CAR-T cell therapies; Gene therapies; Immunotherapies
Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Mantle-cell lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma; Chronic lymphocytic leukaemia
New Molecular Entity No

Marketed Mantle-cell lymphoma; Precursor B-cell lymphoblastic leukaemia-lymphoma
Phase II Burkitt's lymphoma; Haematological malignancies; Hairy cell leukaemia; Richter's syndrome; Solid tumours; Waldenstrom's macroglobulinaemia
Phase I/II Non-Hodgkin's lymphoma
Discontinued Chronic lymphocytic leukaemia

27 Feb 2025 Kite terminates phase II ZUMA-25 clinical trial in Hairy cell leukaemia, Waldenstrom's macroglobulinaemia, Richter's syndrome and Burkitt's lymphoma (Second-line therapy or greater) in US, France, Italy, the Netherlands, Spain, Austria, Germany and Switzerland (IV) due to sponsor decision (NCT05537766)
07 Dec 2024 Efficacy and adverse event data from the phase II ZUMA-2 trial in Mantle cell lymphoma presented at the 66th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2024)
07 Dec 2024 Efficacy, pharmacokinetics and adverse event data from the phase II ZUMA-2 trial in Mantle cell lymphoma presented at the 66^th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2024)

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