YESCARTA (Gilead Sciences Pty Ltd)
Product name
YESCARTA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
193 (255 working days)
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: Large B-cell Lymphoma - Patients with relapsed or refractory large B-cell lymphoma (LBCL). YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma. Follicular Lymphoma - Patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.