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Have you wondered how many cell and gene therapies (CGTs) have been approved in Canada? So did I.

To track the number down, I first turned to my trusty internet search engine with hopes that a list of Health Canada-approved CGTs would already exist online. Notably, it was exciting to see that one of the top results was Aileen Zhou’s 2022 Signals blog post called “The Canadian regulatory system for cell and gene therapies,” though this post listed approved CGTs from two years ago. I couldn’t find a more current resource, so I realized I needed to do additional research to find out how many authorized CGTs there are in Canada now.

As the results of my sleuthing will be helpful for me and my colleagues to have on hand, we thought that others in the field would benefit from having access to an up-to-date list of Canada’s approved CGTs too.

Please read on for the list, which is current as of early June 2024. Bookmark this post for future reference!

Cell and gene therapies approved in Canada

• Breyanzi (Bristol-Myers Squibb), a chimeric antigen receptor (CAR) T-cell therapy indicated for the treatment of relapsed or refractory (R/R) large B-cell lymphoma, was approved in March 2024.
• Beqvez (Pfizer), an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of hemophilia B, was approved in December 2023.
• Hemgenix (CSL), an AAV vector-based gene therapy indicated for the treatment of hemophilia B, was approved in October 2023.
• Carvykti (Janssen), a CAR T-cell therapy indicated for the treatment of multiple myeloma, was approved in February 2023.
• Tecartus (Kite, Gilead), a CAR T-cell therapy indicated for the treatment of mantel cell lymphoma, was first approved in December 2021. A second indication, R/R B-cell precursor acute lymphoblastic leukemia, was approved in October 2023.
• Abecma (Celgene), a CAR T-cell therapy indicated for the treatment of R/R multiple myeloma, was approved in May 2021.
• Zolgensma (Novartis), an AAV vector-based gene therapy indicated for the treatment of spinal muscular atrophy, was approved in March 2021.
• Luxturna (Spark), a gene therapy indicated for the treatment of a rare form of inherited vision loss, was approved in August 2019.
• Yescarta (Kite, Gilead), a CAR T-cell therapy indicated for the treatment of large B-cell lymphoma, was approved in August 2019.
• Kymriah (Novartis), a CAR T-cell therapy indicated for the treatment of diffuse large B-cell lymphoma, was approved in September 2018.
• Prochymal (Mesoblast), a bone marrow–derived mesenchymal stem cell treatment indicated for the treatment of graft-versus-host disease in pediatric patients, was approved in May 2012.

If you’d like to find out more about the CGTs listed above, visit Health Canada’s Drug Product Database and search by product name.

For CGT approvals in countries/regions beyond Canada, including the United States, European Union, Japan and more, the American Society of Gene and Cell Therapy (ASGCT) and Citeline prepare a summary of global approvals on a quarterly basis. This report also covers CGTs in clinical trials. Review the most recent version, which was published in April 2024, for more information.

As a disclaimer, I noticed that three of the Health Canada-approved CGTs (Carvykti, Tecartus and Prochymal) were missing from the ASGCT and Citeline report. Therefore, please refer to the bullets above for a comprehensive list of Canadian approvals. Further, I’d recommend double-checking the other international approvals in the ASGCT and Citeline report, as required.

Looking forward, with more than 2,000 CGTs in clinical trials worldwide, you may be wondering how regulators plan to manage the review and authorization of so many products in the pipeline. An episode from the latest season of the Commercializing Living Therapies with CCRM podcast tackles this topic in an interview with Drs. Michael Rosu-Myles, Executive Director, Health Canada, and Josephine Lembong, Senior Manager, Science and Industry Affairs, Alliance for Regenerative Medicine. Listen on CCRM’s website or wherever you stream podcasts to find out how regulators have created new frameworks and offices to enhance their ability to review submissions.

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Laine Bodnar

Laine Bodnar is the Senior Manager Communications at CCRM. Laine has a thorough understanding of health communications, having previously worked in public relations agencies with clients in the pharmaceuticals, biologics, consumer health, medical device and nutrition industries. At CCRM, she is generating awareness of the ever-advancing regenerative medicine and cell and gene therapy fields as she supports the company with strategic communications. Laine completed an Honours Bachelor of Arts degree in Communication Studies at Wilfrid Laurier University in Waterloo, Canada, and a Postgraduate Certificate in Public Relations at Humber College in Toronto, Canada. Follow Laine on Twitter @LaineBComms.

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