Comparative real-world pharmacovigilance analysis of adverse event signals associated with six approved CAR-T products using the FAERS database.

Research overview

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ObjectiveAlthough several CAR-T products have been approved for hematologic malignancies, their post-marketing adverse-event reporting patterns may not be interchangeable. This study compared FAERS-derived positive signals across approved CAR-T products to distinguish recurrent class-related toxicities from product-skewed reporting patterns.MethodsFAERS reports from Q1 2014 to Q2 2025 were reviewed for CAR-T products. Demographic characteristics were summarized for seven products, whereas PT- and SOC-level signal analyses were restricted to six products with sufficient signal data: Breyanzi, Kymriah, Tecartus, Yescarta, Abecma, and Carvykti. Positive signals were detected using ROR, PRR, and BCPNN algorithms. After predefined exclusion of nonclinical or non-AE terms, indication- or disease-progression-related terms, procedure- or investigation-related terms, efficacy- or persistence-related terms, and product-quality-related terms, eligible signals were compared at the PT and SOC levels. Nonspecific MedDRA-coded PTs were retained if they met the predefined signal criteria, but they were interpreted descriptively and were not used to define product-level profile labels.ResultsCRS was consistently among the leading PT-level signals across all six products. Yescarta and Tecartus showed higher reporting of ICANS and neurotoxicity-related PTs. Kymriah was more strongly represented by infection-, immune-, and hematologic-related signals, whereas Carvykti showed several neurologic PTs including Parkinsonism, cranial nerve paralysis, facial paralysis, and Bell's palsy. Abecma showed relatively high-ranking systemic symptom-related PTs, including fatigue, headache, and decreased appetite. At the SOC level, nervous system disorders and infections and infestations were among the most frequently represented categories, but their proportions differed across products.ConclusionFAERS-based signal detection showed a common CAR-T reporting backbone centered on CRS, ICANS/neurotoxicity, hypotension, pyrexia, infection-related events, and hematologic events, together with product-skewed signal patterns. These findings represent disproportionality signals rather than comparative safety rankings, and FAERS data cannot establish causal relationships between CAR-T products and adverse events.

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