{"title":"Inlexzo (gemcitabine intravesical system): promising data but key questions remain.","authors":"Zarmeen Azhar, Zehra Sadia","doi":"10.1007/s00345-025-05955-0","DOIUrl":null,"url":null,"abstract":"<p><p>The FDA approval of Inlexzo (gemcitabine intravesical system, formerly TAR-200) for BCG-refractory non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ is a milestone achievement in bladder-sparing therapy. Outcomes from the SunRISe-1 trial showed an outstanding 3-month complete response rate of 82%, and sustainability in more than half of responders at 12 months. Yet enthusiasm must be balanced with significant cautions: lack of comparator arm, immature long-term survival data, and practical issues with indwelling intravesical delivery, risk of infection, and access in low-resource environments. While Inlexzo is promising in a population where alternatives are scarce, its place must be clarified by longer-term follow-up, randomized comparisons versus systemic and intravesical therapies, and real-world experience. Prior to that, clinicians must utilize open counseling and shared decision-making.</p>","PeriodicalId":23954,"journal":{"name":"World Journal of Urology","volume":"43 1","pages":"586"},"PeriodicalIF":2.9000,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"World Journal of Urology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00345-025-05955-0","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
The FDA approval of Inlexzo (gemcitabine intravesical system, formerly TAR-200) for BCG-refractory non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ is a milestone achievement in bladder-sparing therapy. Outcomes from the SunRISe-1 trial showed an outstanding 3-month complete response rate of 82%, and sustainability in more than half of responders at 12 months. Yet enthusiasm must be balanced with significant cautions: lack of comparator arm, immature long-term survival data, and practical issues with indwelling intravesical delivery, risk of infection, and access in low-resource environments. While Inlexzo is promising in a population where alternatives are scarce, its place must be clarified by longer-term follow-up, randomized comparisons versus systemic and intravesical therapies, and real-world experience. Prior to that, clinicians must utilize open counseling and shared decision-making.
期刊介绍:
The WORLD JOURNAL OF UROLOGY conveys regularly the essential results of urological research and their practical and clinical relevance to a broad audience of urologists in research and clinical practice. In order to guarantee a balanced program, articles are published to reflect the developments in all fields of urology on an internationally advanced level. Each issue treats a main topic in review articles of invited international experts. Free papers are unrelated articles to the main topic.