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Tecartus FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 4, 2021.

FDA Approved: Yes (First approved July 24, 2020)
Brand name: Tecartus
Generic name: brexucabtagene autoleucel
Dosage form: Suspension for Intravenous Infusion
Previous Name: KTE-X19
Company: Kite, a Gilead Company
Treatment for: Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia

Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy for the treatment of mantle cell lymphoma (MCL) and B-cell precursor acute lymphoblastic leukemia (ALL).

  • Tecartus is 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).
  • Tecartus is an autologous, anti-CD19 CAR T-cell therapy. It is made from the patient's own white blood cells which have been modified to recognize and attack the lymphoma cells.
  • Tecartus is administered via intravenous infusion.
  • The Tecartus product label carries a boxed warning for cytokine release syndrome and neurologic toxicities. Because of this risk, Tecartus is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Tecartus REMS Program.
  • Tecartus may cause serious adverse reactions including hemophagocytic lymphohistiocytosis/macrophage activation syndrome, hypersensitivity reactions, severe infections, prolonged cytopenias, hypogammaglobulinemia, secondary malignancies, and imparied ability to drive and use machines.
  • Common side effects in MCL patients include fever, CRS, hypotension, encephalopathy, fatigue, tachycardia, arrhythmia, infection with pathogen unspecified, chills, hypoxia, cough, tremor, musculoskeletal pain, headache, nausea, edema, motor dysfunction, constipation, diarrhea, decreased appetite, dyspnea, rash, insomnia, pleural effusion, and aphasia.
  • Common side effects in ALL patients include fever, CRS, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting.

Development timeline for Tecartus

Oct  1, 2021Approval U.S. FDA Approves Kite’s Tecartus as the First and Only CAR-T for Adults with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
Jul 24, 2020Approval FDA Approves Tecartus (brexucabtagene autoleucel) as the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma
Feb 10, 2020U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma
Dec 11, 2019Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy KTE-X19
Jun  1, 2019Kite Announces End of Phase 1 ZUMA-3 Results for KTE-X19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.