TECARTUS
STN: BL 125703
Proper Name: brexucabtagene autoleucel
Tradename: TECARTUS
Manufacturer: Kite Pharmaceuticals, Inc.
TECARTUS is indicated for the treatment of:
- Adult patients with relapsed or refractory mantle cell lymphoma (MCL).
- Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
- Package Insert and Medication Guide - TECARTUS
- Demographic Subgroup Information - TECARTUS (brexucabtagene autoleucel)
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
- June 16, 2026 Approval Letter - TECARTUS
- April 1, 2026 Approval Letter - TECARTUS
- October 21, 2025 Approval Letter - TECARTUS
- June 26, 2025 REMS Elimination Approval Letter – TECARTUS
- 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