mPost-marketing Safety Assessment of Tisagenlecleucel: Analysis of Individual Case Safety Reports in VigiBase

Alorf et al discuss their mPost-marketing safety assessment of tisagenlecleucel. Tisagenlecleucel is the first Chimeric Antigen Receptor (CAR)-T cell therapy approved by Saudi Food and Drug Authority (SFDA) for B-cell lymphomas and leukemia treatment. Based on the analysis performed, the retrieved d...

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Bibliographic Details
Published in:Drug safety 2023-11, Vol.46 (11), p.1193-1194
Main Authors: Alorf, N, Alhawas, S, Alfadel, N
Format: Article
Language:English
Subjects:
Antigens
B-cell lymphoma
Cardiac arrhythmia
Cell therapy
Chimeric antigen receptors
Leukemia
Lymphocytes
Lymphocytes B
Lymphocytes T
Marketing
Pharmacovigilance
Safety
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Summary:Alorf et al discuss their mPost-marketing safety assessment of tisagenlecleucel. Tisagenlecleucel is the first Chimeric Antigen Receptor (CAR)-T cell therapy approved by Saudi Food and Drug Authority (SFDA) for B-cell lymphomas and leukemia treatment. Based on the analysis performed, the retrieved data from ADE reports reveal no new or unexpected safety information. However, it highlights considerable variability in the quality and completeness of ADE reports. Incomplete data is a known limitation of drug safety surveillance based on ADE reporting after marketing authorization and our evaluation indicates this is also true for CAR-T-cell products.
ISSN:0114-5916
1179-1942