STN: BL 125643
Proper Name: axicabtagene ciloleucel
Trade Name: YESCARTA
Manufacturer: Kite Pharma Inc.
Indication:
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:
Product Information
Supporting Documents
- June 26, 2025 Approval Letter – YESCARTA
- June 12, 2024 Approval Letter – YESCARTA
- June 12, 2024 REMS Major Modification Approval Letter – YESCARTA
- April 12, 2024 Approval Letter – YESCARTA
- March 1, 2024 Approval Letter – YESCARTA
- December 21, 2023 Approval Letter – YESCARTA
- 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
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Content current as of:
06/27/2025
