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Home > Industry News > Novartis receives Health Canada approval of its CAR-T cell therapy, Kymriah™ (tisagenlecleucel)i

Novartis receives Health Canada approval of its CAR-T cell therapy, Kymriah™ (tisagenlecleucel)i

Novartis receives Health Canada approval of its CAR-T cell therapy, Kymriah™ (tisagenlecleucel)i2018.09.07

DORVAL, QCSept. 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.

Health Canada has approved Kymriah for use in pediatric and young adult patients 3 to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) who are refractory, have relapsed after allogenic stem cell transplant (SCT) or are otherwise ineligible for SCT, or have experienced second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphomai.

Kymriah is a one-time treatment that uses a patient's own T cells to fight and kill cancer cells. Bringing this innovative therapy to Canadian patients requires collaboration among many health system stakeholders. Regulatory approval is an important first step; certification and training at key qualified treatment centres for the appropriate indications are underway to facilitate safe and seamless delivery to patients. Novartis also continues to enhance manufacturing capacity to meet patient needs in both indications.

"This first approval of a CAR-T cell therapy in Canada heralds the start of what promises to be a new age in the way cancer is treated. Novartis is working collaboratively with a number of treatment centres to build a delivery system that did not previously exist," said Daniel Hébert Medical Director, Novartis Pharmaceuticals Canada Inc. "Kymriah is a concrete demonstration of our commitment to reimagine medicine and to develop new practice-changing technologies."

Pioneering Technology

CAR-T cell therapy represents a significant step forward in treating these cancers and is the embodiment of personalized medicine. Kymriah is manufactured individually for each patient using their own cells. It is not a pill or traditional chemotherapy but instead is produced via pioneering technology and a sophisticated manufacturing process. The one-time therapy uses the patient's T cells, a type of white blood cell, which are harvested from a patient's blood, frozen and then transported to the Novartis manufacturing facility. They are then modified to create T cells that are genetically coded to recognize, fight and kill cancer cells and other B-cells expressing a specific antigen. The resulting therapy is returned to the treatment centre and administered to the patient via infusion in one session.

"This is an exciting step forward. We have been looking forward to the approval of CAR-T cell therapy, so we can offer an important and promising new treatment option to young patients we see with refractory or relapsed B-cell acute lymphoblastic leukemia who have exhausted other treatment options," said Dr. Henrique Bittencourt, hematologist at the Centre hospitalier universitaire Sainte-Justine (CHU Sainte-Justine) in Montreal and assistant clinical professor, Department of Pediatrics, University of Montreal.  "This is a new era of cell therapy that offers an opportunity to these very sick children and youth."

"This innovation in cancer treatment opens the door to a new care approach for individuals for whom traditional therapies such as chemotherapy, radiation and surgery are not an option," said Dr. Ronan Foley, Site Principal Investigator, JULIET Clinical Trial, Juravinski Hospital and Cancer Centre, Hamilton Health Sciences and McMaster University; Professor, Department of Pathology and Molecular Medicine, Faculty of Health Sciences, McMaster University; and Director, Stem Cell Laboratory, Hamilton Health Sciences. "CAR-T cell therapy uniquely harnesses the potential of the individual's own immune system to target and destroy cancer cells. It is a major advancement in the emergence of immune-based strategies and shows great promise as a potentially life-saving treatment in cancer care."

The pediatric treatment centre in Ontario where tisagenlecleucel CAR-T cell therapy was delivered is The Hospital for Sick Children (SickKids) in Toronto.

SOURCE Novartis Pharmaceuticals Canada Inc.

 

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