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December 8, 2025Blood

Real-world patterns of secondary malignancies and relapse following CAR T-cell therapy: A faers pharmacovigilance analysis

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Authors

SSSheilabi SeeburunMCMohamad Cherry

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Overview

Pharmacovigilance analysis shows neoplasms in patients after CAR T-cell therapy, suggesting need for surveillance.

Key Points

  • This analysis aims to characterize secondary malignancies and relapse patterns following CAR T-cell therapy.
  • Retrospective analysis using FAERS reports from product approval through Q1 2025
  • Focused on neoplasms reported after CAR T-cell therapy
  • Analyzed demographics, malignancy subtypes, and outcomes descriptively.
  • 2,722 neoplasm-related adverse events identified (19.9% of total reported)
  • Distinct event patterns observed for different CAR T-cell products
  • High mortality reported in Tisa-cel (41.4%) and Axi-cel (40.2%) cases.

Cite This Study

Seeburun et al. (2025) studied this question.

synapsesocial.com/papers/69362f744fa91c937236e27fhttps://doi.org/10.1182/blood-2025-7669
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Treatment-Related Myelodysplastic Syndrome and Acute Myeloid Leukemia Associated with CAR T-Cell Therapies: A Real-World FAERS Pharmacovigilance Study2026 · 1 citations
  2. 2Treatment-Related Myelodysplastic Syndrome and Acute Myeloid Leukemia Associated with CAR T-Cell Therapies : A Real-World FAERS Pharmacovigilance Study2026
  3. 3A post-marketing pharmacovigilance analysis of cardiotoxicities following chimeric antigen receptor T-cell therapy using the FDA adverse event reporting system2025
  4. 4Adverse Events of CD19- and BCMA-Directed Chimeric Antigen Receptor T-Cell Therapy: An Analysis of the FDA Adverse Events Database2026
  5. 5Safety assessment of anti-B cell maturation antigen chimeric antigen receptor T cell therapy: a real-world study based on the FDA adverse event reporting system database2024 · 8 citations