YESCARTA (axicabtagene ciloleucel)

STN: BL 125643
Proper Name: axicabtagene ciloleucel
Trade Name: YESCARTA
Manufacturer: Kite Pharma, Incorporated
Indication:

•  A CD19-directed genetically modified autologous T cell immunotherapy indicated for the 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.

 

Product Information

• Package Insert - YESCARTA
• Demographic Subgroup Information - axicabtagene ciloleucel (YESCARTA)

Supporting Documents

• 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