Comparative real-world pharmacovigilance analysis of adverse event signals associated with six approved CAR-T products using the FAERS database.
- 1Hunan Provincial Key Laboratory of Basic and Clinical Pharmacological Research of Gastrointestinal Cancer, Department of Pharmacy, Institute of Pharmacy and Pharmacology, The Second Affiliated Hospital, University of South China, Hengyang, Hunan, China.
- 2Hengyang Medical School, University of South China, Hengyang, Hunan, China.
Abstract
Objective
Although 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.Methods
FAERS 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.Results
CRS 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.Conclusion
FAERS-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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BibTeX
@article{xiao2026comparative,
title = {{Comparative real-world pharmacovigilance analysis of adverse event signals associated with six approved CAR-T products using the FAERS database.}},
author = {Shengyuan Xiao and Ying Li and Hui Wang and Longcai Tong and Rong Li},
journal = {Frontiers in pharmacology},
year = {2026},
month = oct,
doi = {10.3389/fphar.2026.1913235},
url = {https://europepmc.org/article/MED/42908664},
note = {CC BY},
}
RIS
TY - JOUR
TI - Comparative real-world pharmacovigilance analysis of adverse event signals associated with six approved CAR-T products using the FAERS database.
AU - Shengyuan Xiao
AU - Ying Li
AU - Hui Wang
AU - Longcai Tong
AU - Rong Li
PY - 2026
DA - 2026/10/07
JO - Frontiers in pharmacology
DO - 10.3389/fphar.2026.1913235
UR - https://europepmc.org/article/MED/42908664
AB - Objective Although 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.Methods FAERS 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.Results CRS 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.Conclusion FAERS-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.
SN - 1663-9812
ER -