STN: BL 125703
Proper Name: brexucabtagene autoleucel
Manufacturer: Kite Pharma, Inc.
- Adult patients with relapsed or refractory mantle cell lymphoma (MCL). New Indication for this supplement: Adult patients with relapsed or refractory (r/r) B-cell
precursor acute lymphoblastic leukemia (ALL)
- Package Insert - 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.
- October 1, 2021 Approval Letter - 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