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
- June 26, 2025 Approval Letter – TECARTUS
- June 12, 2024 Approval Letter – TECARTUS
- June 12, 2024 REMS Major Modification Approval Letter – TECARTUS
- April 12, 2024 Approval Letter – TECARTUS
- December 11, 2023 Approval Letter – TECARTUS
- October 1, 2021 Approval Letter – TECARTUS
- October 1, 2021 Clinical Pharmacology Memo – TECARTUS
- October 1, 2021 Clinical Review and Evaluation – TECARTUS
- Pharmacology/Toxicology Review – TECARTUS
- Statistical Review – TECARTUS
- February 24, 2021 Approval Letter – TECARTUS
- July 24, 2020 Approval Letter – TECARTUS
- July 23, 2020 Summary Basis for Regulatory Action – TECARTUS
- Approved Risk Evaluation and Mitigation Strategies (REMS) – TECARTUS
- Approval History, Letters, Reviews, and Related Documents – TECARTUS
-
Content current as of:
06/27/2025
