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

Sep 23, 2026

Uploaded by McQueen

Some novel anticancer agents are linked to drug-induced interstitial lung disease (ILD), a critical and potentially fatal adverse event, and lung cancer patients may be especially vulnerable. A retrospective pharmacovigilance analysis assessed ILD risk and clinical characteristics induced by FDA-approved novel anticancer agents in non-small cell lung cancer (NSCLC) using FAERS reports from 2014–2024. Among 4712 cases, eight agents showed positive ILD signals, with a median onset of 33 days and nearly half occurring within the first month, while fatal cases had shorter onset and patient factors influenced risk and mortality.

LanguageEnglish

CategoryHealthcare

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Pages15

Reading Time38 min

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Abstract

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Introduction

TherapeuTic advances in respiratory disease Original Research Interstitial lung disease associated with novel anticancer agents in non-small cell lung cancer: a pharmacovigilance analysis using the FAERS database Yunfei Zhu, Jingjing Sun and Shuyun Xu Abstract Background: Some novel anticancer agents are associated with drug-induced interstitial lung disease (ILD), a critical and potentially fatal adverse event. Lung cancer patients appear particularly susceptible, yet the risk and clinical characteristics remain incompletely analyzed. Objectives: To comprehensively evaluate ILD risk and characteristics induced by novel anticancer agents in non-small cell lung cancer (NSCLC) using large-scale real-world data. Design: A retrospective pharmacovigilance study based on spontaneous adverse event reports. Methods: Data from 2014 to 2024 were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) . Reports of NSCLC patients who developed ILD during treatment with FDA-approved novel anticancer agents (immune checkpoint inhibitors, targeted therapies, antibody-drug conjugates) . The reporting odds ratio (ROR) was used to assess the disproportionate reporting signals for each drug. Statistical significance was defined when the lower 95% confidence interval (CI) exceeded 1 with at least three reports. Results: A total of 4712 NSCLC cases were analyzed. Eight agents were identified with positive signals for ILD: ROR and 95% CI for nivolumab was 1.28 (1 .20–1.38), pembrolizumab 1.47 (1 .36–1. 59), durvalumab 7.38 (6 .90–7.89), atezolizumab 1.25 (1 .12–1.39), ipilimumab 1.96 (1 .74– 2. 21), tremelimumab 3.58 (1 .97–6. 50), trastuzumab-deruxtecan 3.14 (2 .29–4.30), osimertinib 1.12 (1 .03–1. 23) . The median onset time was 33 days, with 48. 59% of ILD events occurring within the first month. The fatal cases experienced a significantly shorter onset time than nonfatal cases. Older age, male sex, and lower body weight were identified as factors affecting ILD, whereas lower body weight, male sex, and a higher number of concomitant drugs were linked to increased mortality. Conclusion: Our study identifies positive signals for ILD with eight novel antineoplastic agents in NSCLC, including nivolumab, pembrolizumab, durvalumab, atezolizumab, ipilimumab, tremelimumab, trastuzumab-deruxtecan, and osimertinib, highlights the importance of monitoring during the first month of therapy, and identifies older male patients with lower body weight as a high-risk group. Plain language summary Understanding the risk of interstitial lung disease from novel anticancer agents in NSCLC patients Why was the study done? Novel anticancer agents, including targeted therapies, immune checkpoint inhibitors (ICIs), and antibody-drug conjugates (ADCs), have improved outcomes for patients with non- TherAdv Respir Dis 2026, Vol. 20: 1–15 DOI: 10. 1177/ 17534666261444082 © The Author(s), 2026. Article reuse guidelines: [sagepub.com/journals](sagepub.com/journals)permissions Correspondence to: Shuyun Xu Department of Respiratory and Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China [sxu@hust.edu.cn](sxu@hust.edu.cn) Yunfei Zhu Jingjing Sun Department of Respiratory and Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [journals.sagepub.com/home/tar](journals.sagepub.com/home/tar) 1 Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ([https://creativecommons.org/licenses/by-nc/4.0/](https://creativecommons.org/licenses/by-nc/4.0/)) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the Sage and Open Access pages ([https://us.sagepub.com/en-

FAQs

What was the main purpose of the study?

To comprehensively evaluate ILD risk and clinical characteristics induced by novel anticancer agents in NSCLC using large-scale real-world FAERS data.

How was ILD risk quantified in the analysis?

Using the reporting odds ratio (ROR) to identify disproportionate reporting signals for each drug, with statistical significance based on the lower 95% confidence interval exceeding 1 and at least three reports.

Which drugs showed positive signals for ILD and when did ILD most often start?

Eight agents showed positive signals: nivolumab, pembrolizumab, durvalumab, atezolizumab, ipilimumab, tremelimumab, trastuzumab-deruxtecan, and osimertinib. The median onset was 33 days, and 48.59% of events occurred within the first month.

Sep 23, 2026

Uploaded by McQueen