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Neoplasm Adverse Events Associated With Anti-Type 2 Biologics: An FAERS Database Pharmacovigilance Analysis Study.
Wen Lyu1,2,3,4, Rui Xu1,2,3,4, Lin Chen1,2,3,4
1Department of Otorhinolaryngology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.
Cancer Medicine
|May 25, 2026
Summary
Anti-Type 2 biologics, used for conditions like asthma, showed potential links to cancer events in a safety analysis. Clinicians should monitor patients for neoplasm risks during long-term treatment.
Area of Science:
- Immunology
- Pharmacovigilance
- Oncology
Background:
- Biologics targeting Type 2 immune responses are increasingly prescribed.
- Emerging evidence suggests potential associations between these biologics and neoplastic events.
Purpose of the Study:
- To investigate potential associations between anti-Type 2 biologics and neoplasm-related adverse events.
- To analyze the FDA Adverse Event Reporting System (FAERS) database for signals of disproportionality.
Main Methods:
- Analysis of FAERS data for omalizumab, dupilumab, benralizumab, reslizumab, and mepolizumab in asthma patients.
- Disproportionality analysis and multivariable logistic regression were employed to assess neoplasm-related adverse events.
Main Results:
- A total of 2316 neoplasm-related adverse event reports were identified across the studied biologics.
- Significant disproportionality signals for neoplasms, including breast, lung, and prostate cancers, were observed for all biologics.
- Dupilumab showed a specific signal for cutaneous T-cell lymphoma.
Conclusions:
- This pharmacovigilance study detected neoplasm-related disproportionality signals for anti-Type 2 biologics.
- Causality cannot be established due to spontaneous reporting limitations.
- Clinicians should maintain vigilance for neoplasm risks in patients receiving long-term anti-Type 2 biologic therapy.
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