Yescarta™ is positioned to join Kymriah™ as the second chimeric antigen receptor T cell (CAR-T) therapy to achieve regulatory approval in Canada, based on exciting news released this month from Gilead Sciences Canada. [Read more…]
Australian TGA Approves Novartis’ Kymriah® CAR-T Therapy for Two Blood Cancers
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]
Cellular Biomedicine Group (CBMG) to Manufacture Kymriah® for Novartis in China
On September 27, 2018, Cellular Biomedicine Group Inc. (NASDAQ: CBMG) announced it entered into a strategic licensing and collaboration agreement with Novartis to manufacture and supply the CAR-T cell therapy Kymriah® in China. [Read more…]
Novartis Receives Health Canada Approval of its CAR-T cell therapy, Kymriah™
- 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…]
CAR-T Manufacturing | Novartis Selects French CDMO CELLforCURE
CELLforCURE is a French pharmaceutical group that is authorized to do CAR-T manufacturing at its bioproduction site in Les Ulis (Essonne). CELLforCURE holds two Good Manufacturing Practice (GMP) certificates that allows it to manufacture experimental and commercial cell and gene therapies.
On July 10, 2018, CELLforCURE signed an agreement to manufacture CAR-T products for Novartis. Under the terms of the agreement, CELLforCURE will produce cancer CAR-T therapies (“chimeric antigen receptor T-cells”).
Production is scheduled to begin in 2019 following transfer of Novartis’ CAR-T manufacturing technology to CELLforCURE. [Read more…]
