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APR 2 2026
APPROVED · 62 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 an aggressive form of non-Hodgkin's lymphoma that originates in the lymph nodes and often resists standard treatments. Tecartus is a CAR T-cell therapy that genetically reprograms a patient's own immune cells to recognize and attack lymphoma cells bearing a specific marker. This targeted approach may offer a new option for patients whose cancer has returned or stopped responding to other therapies.

Pivotal trial

ZUMA-2 Phase 2 completed NCT04880434

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