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Australian TGA Approves Novartis’ Kymriah® CAR-T Therapy for Two Blood Cancers

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Kymriah® (tisagenlecleucel), CAR-T therapy from Novartis, receives TGA approval for treating two aggressive blood cancers

  • Kymriah® is an immunocellular therapy that is a one-time treatment manufactured individually for each patient using the patient’s own T cells, genetically reengineered and programmed to recognise and destroy cancer cells.
  • Kymriah® is approved for the treatment of relapsed or refractory patients with paediatric B-cell acute lymphoblastic leukaemia (ALL) and adult diffuse large B-cell lymphoma (DLBCL)[1]
  • Kymriah® could be a treatment option for about 50 paediatric and young adult ALL patients and 420 adult DLBCL patients who relapse or do not respond to initial therapy[2]
  • Kymriah® is the only chimeric antigen receptor T cell (CAR-T) therapy to receive TGA approval in Australia[1]

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Novartis Receives Health Canada Approval of its CAR-T cell therapy, Kymriah™

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  • Kymriah, the first chimeric antigen receptor T cell (CAR-T) therapy approved in Canada, is manufactured individually for each patient
  • Novartis is working with qualified treatment centres to prepare for the delivery of this treatment for relapsed/refractory (r/r) pediatric and young adult B-cell ALL and adult r/r DLBCL indications

DORVAL, QC, Sept. 6, 2018 – Novartis is pleased to announce that following a Priority Review, Health Canada has approved Kymriah™ (tisagenlecleucel/ CTL019) the first chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in Canada.

Kymriah, a CD19-directed genetically modified autologous T-cell immunocellular therapy, is approved to treat two life-threatening cancers that have limited treatment options and historically poor outcomes, demonstrating the critical need for new therapies for these patients. [Read more…]

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