BREYANZI® CAR T Cell Therapy Monitoring and Activity Updates Approved in Canada
Canadian product monograph changes may provide patients greater flexibility following treatment
The updated guidance includes a reduction in the recommended duration for patients to remain in close proximity to a specialized treatment centre from 28 days to 14 days following infusion, as well as a reduction in driving restrictions from eight weeks to four weeks. Clinical decisions regarding patient discharge and ongoing monitoring will continue to be determined by the treating healthcare professional based on individual patient needs.
The product monograph updates are supported by a growing body of evidence demonstrating that the risk of treatment-related adverse events decreases significantly after the first 14 days following infusion and are informed by safety data from seven clinical trials involving 691 patients, as well as real-world registry data from 877 patients treated with BREYANZI.
"Clinical experience with BREYANZI has continued to expand in both clinical trial and real-world settings, contributing to a deeper understanding of how patients with relapsed or refractory large B-cell lymphomas can be appropriately monitored following treatment," said Dr. Michael Kennah, a hematologist specializing in cellular therapies at The
The revised monitoring requirements create greater flexibility in follow-up care alleviating capacity pressures at specialized CAR T treatment centres by enabling appropriate patients to transition back to community-based care sooner.
"For patients and their families or caregivers already facing the emotional weight of a cancer diagnosis, the need to travel to receive CAR T cell therapy and remain close to a specialized treatment centre for extended periods can add another layer of stress, as well as logistical and financial strain during an already challenging time," said Antonella Rizza, Chief Executive Officer (CEO), Lymphoma Canada. "The potential for eligible patients to transition home sooner following treatment may help lessen these emotional and practical demands on Canadian patients and their caregivers."
BREYANZI is a personalized cell therapy made using a patient's own white blood cells. These cells are collected from the patient's blood and sent to a specialized facility, where they are reprogrammed to help recognize lymphoma cells. Once returned to the patient's body, the modified cells are designed to identify and attack lymphoma cells.1
"We believe innovation includes not only advancing transformational therapies but also supporting improvements in the overall treatment experience for patients, caregivers and healthcare teams," said
BREYANZI is approved in
For complete prescribing and safety information for BREYANZI, please consult the Canadian product monograph here.
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BREYANZI is a registered trademark of Juno Therapeutics, Inc., used under license by Bristol Myers Squibb Canada.
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- BREYANZI® (lisocabtagene maraleucel) Product Monograph. Available at: https://www.bms.com/assets/bms/ca/documents/productmonograph/BREYANZI_EN_PM.pdf
SOURCE Bristol-Myers Squibb Canada