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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.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/interstitial-lung-disease-associated-with-novel-anticancer-agents-in-non-small-cell-lung-cancer-a-pharmacovigilance-analysis-using-the-faers-database/363342/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/interstitial-lung-disease-associated-with-novel-anticancer-agents-in-non-small-cell-lung-cancer-a-pharmacovigilance-analysis-using-the-faers-database/363342.png","ImageObject",300,407,{"name":92,"@type":93},"McQueen","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-27","2026-09-23",true,{"@type":102,"interactionType":103,"userInteractionCount":39},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What was the main purpose of the study?","Question",{"text":112,"@type":113},"To comprehensively evaluate ILD risk and clinical characteristics induced by novel anticancer agents in NSCLC using large-scale real-world FAERS data.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How was ILD risk quantified in the analysis?",{"text":117,"@type":113},"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.",{"name":119,"@type":110,"acceptedAnswer":120},"Which drugs showed positive signals for ILD and when did ILD most often start?",{"text":121,"@type":113},"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.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},363342,1790492723,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":39,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145},5909890329169,"https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc","TherapeuTic advances in  \nrespiratory disease Original Research  \nInterstitial lung disease associated with novel anticancer agents in non-small cell lung cancer: a pharmacovigilance analysis using the FAERS database  \nYunfei Zhu, Jingjing Sun and Shuyun Xu  \nAbstract  \nBackground: 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.  \nMethods: 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  \n1.12 (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.  \nConclusion: 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.  \nPlain language summary  \nUnderstanding the risk of interstitial lung disease from novel anticancer agents in NSCLC patients  \nWhy was the study done?  \nNovel anticancer agents, including targeted therapies, immune checkpoint inhibitors (ICIs), and antibody-drug conjugates (ADCs), have improved outcomes for patients with non-  \nTherAdv Respir Dis 2026, Vol. 20: 1–15  \nDOI: 10. 1177/ 17534666261444082 © The Author(s), 2026.  \nArticle reuse guidelines: [sagepub.com/journals](sagepub.com/journals)permissions  \nCorrespondence to:  \nShuyun Xu  \nDepartment of Respiratory and Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China  \n[sxu@hust.edu.cn](sxu@hust.edu.cn)  \nYunfei Zhu Jingjing Sun  \nDepartment of Respiratory and Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China  \n[journals.sagepub.com/home/tar](journals.sagepub.com/home/tar) 1  \nCreative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License  \n([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  \nprovided the original work is attributed as specified on the Sage and Open Access pages ([https://us.sagepub.com/en-","cbCaibKU3yptqk1x","https://ap.wps.com/l/cbCaibKU3yptqk1x","pdf",1779476,15,"English","# Abstract\n## Background and Objectives\n## Design and Methods\n## Results\n## Conclusion\n# Plain language summary\n## Why was the study done?\n## What did the researchers do?\n## What did the researchers find?\n## What do the findings mean?\n# Keywords\n# Introduction","[{\"question\":\"What was the main purpose of the study?\",\"answer\":\"To comprehensively evaluate ILD risk and clinical characteristics induced by novel anticancer agents in NSCLC using large-scale real-world FAERS data.\"},{\"question\":\"How was ILD risk quantified in the analysis?\",\"answer\":\"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.\"},{\"question\":\"Which drugs showed positive signals for ILD and when did ILD most often start?\",\"answer\":\"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.\"}]","Interstitial lung disease associated with novel anticancer agents in non-small cell lung cancer - a pharmacovigilance analysis using the FAERS database | PDF",1790150857,38]