STN: BL 125643
Proper Name: axicabtagene ciloleucel
Trade Name: YESCARTA
Manufacturer: Kite Pharma Inc.
For the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma.
- Package Insert - YESCARTA
- Demographic Subgroup Information - axicabtagene ciloleucel (YESCARTA)
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.
- November 2, 2022 Approval Letter - YESCARTA
- April 1, 2022 Approval Letter - YESCARTA
- April 1, 2022 Statistical Review - YESCARTA
- April 1, 2022 Clinical Review and Evaluation - YESCARTA
- April 1, 2022 Clinical Pharmacology Memo - YESCARTA
- January 25, 2022 Approval Letter - YESCARTA
- January 24, 2022 Clinical Memorandum - YESCARTA
- April 22, 2021 Approval Letter - YESCARTA
- April 2, 2021 Approval Letter - YESCARTA
- May 18, 2020 Approval Letter - YESCARTA
- October 18, 2017 Approval Letter - YESCARTA
- October 18, 2017 Summary Basis for Regulatory Action - YESCARTA
- Approval History, Letters, Reviews, and Related Documents - YESCARTA
- Approved Risk Evaluation and Mitigation Strategies (REMS) - YESCARTA