YESCARTA
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 (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, and treatment of adult subjects with relapsed or refractory (r/r) LBCL after 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
- Treatment of adult patients with r/r FL after 2 or more lines of systemic therapy.
Product Information
- Package Insert and Medication Guide - 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.
- February 5, 2026 Approval Letter - YESCARTA
- October 21, 2025 Approval Letter - YESCARTA
- June 26, 2025 REMS Elimination Approval Letter – YESCARTA
- 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