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APR 2 2026
APPROVED · 120 DAYS AGO

Kite Tecartus (brexucabtagene autoleucel)

for relapsed or refractory mantle cell lymphoma

BLA

FDA granted full approval to Kite's CAR T-cell therapy Tecartus for adult patients with relapsed or refractory mantle cell lymphoma.

About

Mantle cell lymphoma is a type of non-Hodgkin's lymphoma that develops in the lymph nodes. Tecartus is a treatment made from a patient's own immune cells, which are genetically engineered to find and attack lymphoma cells. This targeted immune attack may provide a treatment option for patients whose cancer has returned or stopped responding to other therapies.

Pivotal trial

ZUMA-2 Phase 2 completed NCT02601313

The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).

Source: ClinicalTrials.gov

Also in development