STN: BL 125643
Proper Name: axicabtagene ciloleucel
Trade Name: YESCARTA
Manufacturer: Kite Pharma Inc.
Indication:

• Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. 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)

Supporting Documents

• 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