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KYMRIAH (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
KYMRIAH
Date registered
Evaluation commenced
Decision date
Approval time
45 working days (255)
Active ingredients
T Cells - Tisagenlecleucel, cryopreserved - T - Kymriah
Registration type
Biologicals
Indication
Class 4 biological
KYMRIAH is a genetically modified autologous immunocellular therapy indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Kymriah is not indicated for patients with primary central nervous system lymphoma.