Tecartus Real-World Adverse Event Reporting System in a Middle-Aged and Elderly Population: A FAERS-Based Pharmacovigilance Study

BackgroundTecartus (brexucabtagene autoleucel) is an autologous CAR-T product targeting CD19, but there are many undetected and unreported adverse events (AEs).MethodsWe counted data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) from Q4 2020 through Q4 2024 for proportionate analyses to assess the association between Tecartus and adverse events and important medical events (IMEs).ResultA total of 792 datasets related to Tecartus were collected. The following SOCs are significant signals: Nervous system disorders, Infections and infestations, Neoplasms benign, malignant and unspecified (incl cysts and polyps). The most common AEs are cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome and neurotoxicity. With Tecartus, most AEs occur within one month, but AEs can still occur after one year of use.ConclusionBy analysing data from the real-world FAERS database, we identified additional disproportionately reported AEs, providing clinicians with more information about disproportionately reported AEs before and during treatment.