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December 8, 2025Blood

Comparative safety profiles of bispecific T-cell engagers and CAR-T therapies: Real-world insights from the FDA adverse event reporting system database

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Authors

CGCarlos Gálvez

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Overview

Retrospective analysis highlights varied toxicity profiles of CAR-T and BiTE therapies in adverse events.

Key Points

  • To compare the adverse event profiles of CAR-T therapies and BiTEs using real-world data from the FDA.
  • Retrospective pharmacovigilance analysis using FAERS database from 2021 to 2024.
  • Identified AE reports for CAR-T therapies and BiTEs via drug name-based string matching.
  • Calculated disproportionality among adverse events using PRRs, RORs, and 95% confidence intervals.
  • BiTEs showed higher rates of neutropenia (20.2%) versus CAR-T (11.6%).
  • Neurotoxicity was more prevalent in CAR-T therapies (36.1%) compared to BiTEs (5.2%).
  • Cardiotoxicity was reported more often with CAR-T (8.15%) than BiTEs (3.4%).

Cite This Study

Carlos Gálvez (2025) studied this question.

synapsesocial.com/papers/693624dd4fa91c937236d1cehttps://doi.org/10.1182/blood-2025-8038
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Also Consider

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

  1. 1Adverse Events of CD19- and BCMA-Directed Chimeric Antigen Receptor T-Cell Therapy: An Analysis of the FDA Adverse Events Database2026
  2. 2Comparative toxicity profile of chimeric antigen receptor T-cell therapy versus bispecific T-cell engagers in multiple myeloma and B-cell lymphomas: A propensity-matched real-world analysis.2026
  3. 3Comparative cardiovascular and hematologic safety of CAR-T cell therapies and bispecific antibodies: A FAERS-based disproportionality analysis (2022–2024).2025
  4. 4A post-marketing pharmacovigilance analysis of cardiotoxicities following chimeric antigen receptor T-cell therapy using the FDA adverse event reporting system2025
  5. 5Cardiotoxic profiles of CAR-T therapy and bispecific T-cell engagers in hematological cancers2024 · 10 citations