YESCARTA (axicabtagene ciloleucel)
STN: BL 125643
Proper Name: axicabtagene ciloleucel
Trade Name: YESCARTA
Manufacturer: Kite Pharma Inc.
Indication:
-
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.
Product Information
- 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.
Supporting Documents
- 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