The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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.