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Novartis Pharmaceuticals Canada Inc.

04/27/2021 | Press release | Distributed by Public on 04/28/2021 11:53

Alberta sites join network of certified centres to deliver CAR-T therapy, Kymriah® (tisagenlecleucel)i

  • Expansion of treatment centre network includes two specialized centres in Alberta certified to deliver Kymriah to Canadian patients with relapsed/refractory (r/r) pediatric and young adult B-cell ALL and adult r/r DLBCL
  • Alberta joins Quebec and Ontario to reimburse Kymriah therapy for these life-threatening cancers for patients who are in critical needii
  • Kymriah indication now extended for pediatric patients younger than 3 years of age for the treatment of r/r B-cell ALLi

Dorval, QC, April 28, 2021 - Novartis Pharmaceuticals Canada Inc. is pleased to announce that two centres in Alberta have been certified in accordance with applicable requirements, making Kymriah® (tisagenlecleucel) available to certain leukemia and lymphoma patients. Patients with relapsed/refractory (r/r) pediatric and young adult B-cell acute lymphoblastic leukemia (ALL) and adult r/r diffuse large B-cell lymphoma (DLBCL) will be eligible for treatment with Kymriah, the first of its kind chimeric antigen receptor T cell (CAR-T) therapy. This news follows a decision by the Alberta government to reimburse Kymriah; the third Canadian province to implement funding for Kymriah, following Quebec and Ontario.

'This is the news Western Canada has been waiting for. The patients who can be treated with Kymriah are the Canadians who have run out of options and are desperate for hope. This is wonderful news for them,' said Dr. Mona Shafey, hematologist-oncologist, Alberta Health Services, Calgary. 'We are delighted our institution has received certification and are thrilled to be part of the CAR-T treatment network. Patients can now also be treated closer to home which is what anyone would want.'

Joining the specific network of Canadian treatment centres to offer Kymriah are Alberta Children's Hospital, Tom Baker Cancer Centre and Foothills Medical Centre in Calgary. Novartis is committed to build a strong Canadian network of certified, FACT-accredited (Foundation for the Accreditation of Cellular Therapy) sites and provide equity of care across the country.

'Novartis welcomes the centres in Alberta to the network and applauds the Alberta government for its decision to make Kymriah accessible to patients in need. We will continue to live up to our promise to make our life changing therapies available and accessible. This means remaining focused on building a national network of certified sites and collaborating with governments in other provinces to meet the needs of more Canadians,' said Christian Macher, Country President & General Manager, Oncology, Novartis Pharmaceuticals Canada Inc. 'We are proud to have provided Kymriah as a treatment option to more than 100 pediatric and adult Canadians. It is so rewarding to hear the stories of hope across different age groups, and that we are reaching patients who are most in need of Kymriah.'

Kymriah is a one-time treatment that uses a patient's own T cells to identify and kill cancer cells. This unique approach to fighting cancer puts the patient at the centre of the process and its delivery to patients requires collaboration among many different stakeholders.

'This truly is good news for young Canadians living in the West. If you have ever had the opportunity to drive across Canada, you know two things; our country is breathtaking and big. When you have a child with cancer, the option to be treated closer to home and your support network is an incredible gift,' said Chris Collins, Chair, Ac2orn. 'We were also pleased to learn that Health Canada has expanded the age for treatment with Kymriah to now include an even younger pediatric population. This is testament to the positive outcomes we are seeing with CAR-T therapy.'

Due to the sophisticated and individualized nature of Kymriah, treatment sites must be qualified to perform intravenous infusion of stem cells collected from the bone marrow of a donor, also referred to as allogeneic hematopoietic stem cell transplantation (alloSCT) and have experience with cell therapies and treating leukemia and lymphoma to facilitate safe and seamless delivery of Kymriah to eligible patients.

About Kymriah®
Kymriah® (tisagenlecleucel), a CD19-directed genetically modified autologous T-cell immunocellular therapy, is a one-time treatment approved to treat two life-threatening cancers that have limited treatment options and historically poor outcomes, addressing a critical need for new therapies for these patients.

Kymriah is approved by Health Canada for use in pediatric and young adult patients 25 years and younger 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® (tisagenlecleucel) Important Safety Information
The full prescribing information for Kymriah® can be found at: www.novartis.ca

Novartis Leadership in Cell and Gene Therapy
Novartis is at the forefront of investigational immunocellular therapy and was the first pharmaceutical company to significantly invest in CAR-T research, work with pioneers in CAR-T and initiate global CAR-T trials. Active research programs are underway targeting other hematologic malignancies and solid tumors, and include efforts focused on next generation CAR-Ts that involve simplified manufacturing schemes and gene edited cells.

About Novartis Pharmaceuticals Canada
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2020, the company invested $45 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 1,000 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.

About Novartis
Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

Novartis Media Relations
Daphne Weatherby

Novartis Corporate Communications
+1 514 633 7873
E-mail: [email protected]

Kymriah is a registered trademark.

References

1. Novartis Pharmaceuticals Canada Inc., Kymriah® Product Monograph. December 24, 2020.
2. Government of Alberta CAR-T cell therapy funding announcement. Available at: https://www.alberta.ca/release.cfm?xID=78012FBC08931-B687-77E1-22DBC21C0...