U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Vaccines, Blood & Biologics
  3. Cellular & Gene Therapy Products
  4. TECARTUS
  1. Cellular & Gene Therapy Products

TECARTUS

STN: BL 125703
Proper Name: brexucabtagene autoleucel
Tradename: TECARTUS
Manufacturer: Kite Pharmaceuticals, Inc.
Indication: 

TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

  • Adult patients with relapsed or refractory mantle cell lymphoma (MCL).
    This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Product Information

Supporting Documents

Back to Top