Reporting of atrial fibrillation with bispecific T-cell engagers in the Food and Drug Administration Adverse Event Reporting System
Hospital safety data flags a heart rhythm concern with newer cancer immunotherapies, helping doctors watch for this treatable complication.
Analysis of 11.1 million FAERS reports identifies a disproportionate signal for atrial fibrillation with bispecific T-cell engager therapy, driven predominantly by epcoritamab and mosunetuzumab, consistent with the known cytokine release biology of these agents. This safety signal warrants clinician awareness and prospective monitoring as BiTE use expands in hematologic malignancies.
What the study was
- Study design
- Pharmacovigilance (FAERS disproportionality analysis)
- Population
- All FAERS reports Q2 2014 to December 2024; 14,337 BiTE-related ICSRs
- Sample size
- 11129381
- Category
- Drug Development
- Maturity
- Validated
- Journal
- American Journal of Health-System Pharmacy
Why it surfaced
Clinically actionable safety signal for epcoritamab and mosunetuzumab (both FDA/EMA approved for B-cell lymphoma) with direct implications for cardiac monitoring protocols. FAERS analysis is standard-of-care pharmacovigilance with large denominator (11M reports). Bispecific use is rapidly expanding in hematologic malignancies.
A plain-language summary of published research — not medical advice. Talk to a clinician about your own care.