{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T05:16:15Z","timestamp":1778735775545,"version":"3.51.4"},"reference-count":32,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"The authors disclosed receipt of the following financial support for the research, authorship, and\/or publication of this article: This work was supported by Ferring Pharmaceuticals Inc."}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Urology"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:p> Non-muscle-invasive bladder cancer (NMIBC), which is restricted to the mucosa (stage Ta, carcinoma in situ (CIS)) or submucosa (stage T1), comprises 75% of bladder cancer diagnoses. Intravesical bacillus Calmette-Gu\u00e9rin (BCG) therapy is the standard-of-care initial treatment for high-risk NMIBC; however, a significant proportion of patients have BCG-unresponsive disease. While radical cystectomy is a definitive treatment in this setting, not all patients are willing or able to undergo this complex procedure associated with morbidity, mortality, and decreased quality of life. Bladder-preserving options for patients with BCG-unresponsive NMIBC represent an unmet need in this patient population. Nadofaragene firadenovec-vncg (Adstiladrin) is a nonreplicating adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk BCG-unresponsive NMIBC with CIS with or without papillary tumors. The antitumor efficacy of nadofaragene firadenovec is driven by its local delivery of copies of the gene encoding for interferon alpha-2b (IFN\u03b1-2b) to urothelial cells. In the phase III CS-003 study, over half of participants with CIS exhibited a complete response by month 3 after instillation, with minimal serious adverse events. The favorable efficacy and safety profile, clinical utility, novel mechanism of action, and every 3-month dosing schedule give nadofaragene firadenovec a unique role in the treatment of high-risk BCG-unresponsive NMIBC. This review provides a practical approach to the effective clinical use of nadofaragene firadenovec regarding pre-instillation visit arrangements, storage, handling, instillation procedures, and post-instillation procedures. Implementation of these recommendations will ensure efficient real-world use of nadofaragene firadenovec and the development of useful training materials and relevant standard operating procedures to help support a clinic\u2019s treatment for patients with BCG-unresponsive NMIBC with CIS. <\/jats:p><jats:p> Video Abstract https:\/\/vimeo.com\/user17898099\/review\/953723559\/e18af7ec43 <\/jats:p>","DOI":"10.1177\/17562872241280005","type":"journal-article","created":{"date-parts":[[2024,9,18]],"date-time":"2024-09-18T06:55:32Z","timestamp":1726642532000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Clinical use of nadofaragene firadenovec-vncg"],"prefix":"10.1177","volume":"16","author":[{"given":"Badrinath R.","family":"Konety","sequence":"first","affiliation":[{"name":"Allina Health Cancer Institute, Minneapolis, MN, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neal D.","family":"Shore","sequence":"additional","affiliation":[{"name":"Carolina Urologic Research Center, 823 82nd Parkway, Myrtle Beach, SC 29572, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Grannum R.","family":"Sant","sequence":"additional","affiliation":[{"name":"Tufts University School of Medicine, Boston, MA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2024,9,17]]},"reference":[{"key":"bibr1-17562872241280005","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21660"},{"key":"bibr2-17562872241280005","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21763"},{"key":"bibr3-17562872241280005","volume-title":"Presented at 88th Annual Meeting of the New England Section of the American Urological Association","author":"Song J"},{"key":"bibr4-17562872241280005","unstructured":"Mayo Clinic. 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