Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database.
Michele FusaroliValentina IsgròPaola Maria CutroneoCarmen FerrajoloValentina CirilloFrancesca Del BufaloEmanuel RaschiElisabetta PoluzziGianluca TrifiròPublished in: Drug safety (2022)
Our study confirms the well-known adverse drug reactions and detects potentially emerging safety issues specific for each chimeric antigen receptor T-cell therapy, also providing insights into a stronger role for tisa-cel in inducing some immunodeficiency-related events (e.g., hypogammaglobulinemia, infections) and coagulopathies, and for axi-cel in neurotoxicity.