KYMRIAH (Novartis Pharmaceuticals Australia Pty Ltd)
Product name
KYMRIAH
Date registered
Evaluation commenced
Decision date
Approval time
157 working days (255)
Active ingredients
T cells - tisagenlecleucel, cryopreserved - T
Registration type
Biologicals
Indication
Class 4 biological
KYMRIAH is a genetically modified autologous immunocellular therapy indicated for the treatment of paediatric and young adult patients up to 25 years of age with B-cell precursor acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant, or in second or later relapse. KYMRIAH is also 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.