Tecvayli is a treatment for multiple myeloma. It’s used for people who have tried other treatments and haven’t worked. Tecvayli helps T-cells find and destroy cancer cells.
Neurotoxicity in patients using Tecvayli (teclistamab) primarily involves the occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). Tecvayli is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, which means it targets BCMA on multiple myeloma cells and engages T-cells to attack these cancer cells. The mechanisms behind neurotoxicity, including ICANS, are linked to the immune system’s response to this targeted therapy.
ICANS is a result of the activation and proliferation of T-cells, leading to the release of cytokines and other inflammatory mediators.
This immune response can cause a range of neurological symptoms, including confusion, aphasia, seizures, and cerebral edema. The exact pathophysiology of ICANS is not fully understood, but it is believed to involve endothelial activation, blood-brain barrier disruption, and neuroinflammation.
In clinical studies, the frequency and severity of neurotoxic events, including ICANS, have been documented. In the MajesTEC-1 trial, neurotoxicity was observed in a significant number of patients receiving Tecvayli.
The incidence of ICANS was reported to be around 6% in patients treated with Tecvayli. The severity of these events varied, with most cases being mild to moderate (Grade 1 or 2), but some patients experienced severe (Grade 3 or 4) neurotoxicity. The onset of ICANS typically occurred within the first week of treatment, and the duration of symptoms ranged from a few days to several weeks.
Real-world usage data also indicates that neurotoxicity, including ICANS, is a notable adverse event associated with Tecvayli.
Healthcare providers are advised to monitor patients closely for signs of neurotoxicity and manage symptoms promptly to mitigate the impact on patients’ quality of life.
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1www.accessdata.fda.gov2www.tecvaylihcp.com
Monitoring patients closely for signs of neurotoxicity is crucial when using Tecvayli, as it allows healthcare providers to manage symptoms promptly and mitigate their impact on quality of life. The onset of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) typically occurs within the first week of treatment, with symptoms ranging from a few days to several weeks.
Healthcare providers are advised to monitor patients for signs of neurotoxicity, including:
Early intervention is key in managing ICANS, as it can help prevent severe complications. In clinical studies, the frequency and severity of neurotoxic events have been documented, with an incidence of around 6% reported in patients treated with Tecvayli.
Real-world usage data also indicates that neurotoxicity, including ICANS, is a notable adverse event associated with Tecvayli. Therefore, it’s essential for healthcare providers to be vigilant and take proactive steps to prevent or manage neurotoxicity in their patients.
Prompt management of ICANS can help reduce its severity and duration, allowing patients to continue treatment with Tecvayli while minimizing adverse effects. By prioritizing early intervention and close monitoring, healthcare providers can help ensure that patients receive the benefits of Tecvayli while minimizing the risks associated with neurotoxicity.