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May 1, 2026

Interstitial lung disease associated with novel anticancer agents in non-small cell lung cancer: a pharmacovigilance analysis using the FAERS database.

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Authors

YZY Z ZhuJSJingjing SunSXShuyun Xu

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Overview

Retrospective pharmacovigilance analysis detects ILD risk with novel agents in NSCLC, suggesting close monitoring of patients.

Key Points

  • To evaluate the risk and characteristics of interstitial lung disease (ILD) induced by novel anticancer agents in non-small cell lung cancer (NSCLC).
  • Retrospective pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) from 2014 to 2024.
  • Analyzed reports of NSCLC patients treated with FDA-approved novel anticancer agents that resulted in ILD.
  • Used reporting odds ratio (ROR) to assess disproportionate reporting signals for each drug.
  • Analyzed 4712 NSCLC cases; eight agents showed positive signals for ILD: nivolumab (ROR 1.28), pembrolizumab (1.47), durvalumab (7.38), atezolizumab (1.25), ipilimumab (1.96), tremelimumab (3.58), trastuzumab-deruxtecan (3.14), and osimertinib (1.12).
  • Median onset time for ILD was 33 days; 48.59% of cases occurred within the first month.
  • Older age, male sex, and lower body weight were identified as significant risk factors for ILD and mortality.

Cite This Study

Zhu et al. (2026) studied this question.

synapsesocial.com/papers/69f442d4967e944ac55664a4https://doi.org/10.1177/17534666261444082
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