YESCARTA (Gilead Sciences Pty Ltd)
Product name
YESCARTA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
199 working days (255)
Active ingredients
T Cells - axicabtagene ciloleucel, cryopreserved - T - Yescarta
Registration type
Biologicals
Indication
Class 4 biological
YESCARTA is a genetically modified autologous immunocellular therapy for the treatment of 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. YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.