Bristol Myers Squibb Canada has announced updates to the Canadian product monograph for BREYANZI (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor T (CAR T) cell therapy. The changes reduce the duration of certain post-treatment monitoring and activity restrictions for eligible patients following infusion.
Key Updates to Post-Treatment Guidelines
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. Additionally, driving restrictions have been reduced 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.
Evidence Supporting the Changes
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. The data comes from safety information from seven clinical trials involving 691 patients, as well as real-world registry data from 877 patients treated with BREYANZI.
Expert Insights
Dr. Michael Kennah, a hematologist specializing in cellular therapies at The Ottawa Hospital, stated: “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. CAR T cell therapy has transformed outcomes for many patients facing these aggressive lymphomas, and these updates reflect the growing body of evidence and clinical experience informing post-treatment patient management. The revised timelines may support greater flexibility during the post-treatment period and help lessen the logistical and emotional burden associated with care, while maintaining individualized oversight and patient safety.”
Patient and Caregiver Impact
Antonella Rizza, Chief Executive Officer of Lymphoma Canada, commented: “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. 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.”
Benefits for Healthcare System
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.
About BREYANZI
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.
