APR 2 2026
Kite — Tecartus (brexucabtagene autoleucel)
for relapsed or refractory mantle cell lymphoma
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 mantle zone of the lymph nodes, where immune cells grow out of control. Tecartus is a CAR T-cell therapy made by engineering a person's own immune T cells to recognize and attack lymphoma cells. Because it redirects the body's own immune system toward the cancer, it may help people whose mantle cell lymphoma has come back or stopped responding to treatment.
Pivotal trial
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) who have not previously received Bruton's tyrosine kinase inhibitor (BTKi).
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on Tecartus
- Tecartus CAR T Therapy Gains Full FDA Approval - Oncodaily
- Maria Babak: FDA Approves Tecartus in Relapsed or Refractory Mantle Cell Lymphoma - Oncodaily
- FDA Fully Approves Brexucabtagene Autoleucel (Tecartus) for Relapsed or Refractory Mantle Cell Lymphoma - Oncology News Central
- FDA Grants Traditional Approval to Brexucabtagene Autoleucel for Relapsed or Refractory MCL - The ASCO Post
- FDA Grants Full Approval to Tecartus for Relapsed Mantle Cell Lymphoma - Cure Today