{"entity":{"id":"non-muscle-invasive-bladder-cancer","kind":"cancer","name":"Non-muscle-invasive bladder cancer","aka":["NMIBC","Superficial bladder cancer","Ta, T1 and carcinoma in situ of the bladder"],"tldr":"Most bladder cancers are found while still confined to the lining. They are scraped out through the urethra and, when higher risk, treated with BCG instilled into the bladder; the challenge is the frequent recurrences and the patients whose tumours stop responding to BCG.","summary":"Non-muscle-invasive bladder cancer includes papillary tumours confined to the mucosa (Ta) or lamina propria (T1) and flat carcinoma in situ. It is diagnosed by cystoscopy and removed by transurethral resection, with a single immediate dose of intravesical chemotherapy for low-risk tumours. Intermediate- and high-risk disease receives induction and maintenance intravesical BCG, the oldest cancer immunotherapy in use, which halves recurrence and reduces progression. Tumours that recur despite adequate BCG are called BCG-unresponsive; radical cystectomy is the standard, and bladder-sparing alternatives have arrived: pembrolizumab (KEYNOTE-057), nadofaragene firadenovec, nogapendekin alfa inbakicept with BCG, the gemcitabine-releasing device TAR-200 and the oncolytic virus cretostimogene. Worldwide BCG shortages have pushed dose-reduction and chemotherapy substitutes into practice. Blue-light cystoscopy improves detection of flat lesions.","asOf":"2026-09-17","wikipedia":"https://en.wikipedia.org/wiki/Bladder_cancer","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Bladder_cancer"}],"tags":["subtype-page"],"related":["muscle-invasive-bladder-cancer"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["keynote-057"],"people":[],"bottlenecks":[],"keyPapers":["paper-keynote-057-lancet-oncol-2021","paper-nadofaragene-firadenovec-lancet-oncol-2021","paper-sylvester-eortc-risk-tables-eur-urol-2006","paper-eau-nmibc-guideline-eur-urol-2022"],"journals":[],"dependsOn":[],"notes":[],"group":"genitourinary","burden":"About three quarters of new bladder cancers; rarely fatal at this stage but it recurs in half of patients and progresses to muscle invasion in a fifth of the high-risk group, so years of cystoscopic surveillance make it one of the most expensive cancers to manage.","subtypes":["Low-grade Ta papillary tumours (low risk)","High-grade Ta and T1 tumours (high risk)","Carcinoma in situ","BCG-unresponsive disease","Upper tract urothelial carcinoma of the renal pelvis and ureter (related)"],"biomarkers":["Grade and stage (EAU and AUA risk groups)","Carcinoma in situ and lymphovascular invasion","FGFR3 mutations (common in low-grade disease)","Urinary biomarkers and cytology for surveillance","Molecular subtypes under study"],"standardOfCare":[{"setting":"Diagnosis and resection","approach":"Cystoscopy, transurethral resection with muscle in the specimen, blue-light or enhanced imaging for carcinoma in situ; re-resection of T1 tumours.","refs":["urothelial"]},{"setting":"Low risk","approach":"Single immediate instillation of mitomycin or gemcitabine after resection; surveillance cystoscopy.","refs":["mitomycin","gemcitabine"]},{"setting":"Intermediate and high risk","approach":"Induction and one to three years of maintenance BCG; intravesical chemotherapy when BCG is unavailable; early cystectomy for the highest-risk T1 disease.","refs":["bcg-and-intravesical-therapy"]},{"setting":"BCG-unresponsive","approach":"Radical cystectomy, or bladder-sparing treatment: pembrolizumab, nadofaragene firadenovec, nogapendekin alfa inbakicept with BCG, TAR-200, cretostimogene in trials and early approvals.","refs":["cystectomy","pembrolizumab","nadofaragene-firadenovec","nogapendekin-alfa","tar-200","cretostimogene"]}],"stateOfArt":["BCG remains the standard forty years on, and shortages have shown how much depends on one biologic.","Four bladder-sparing options for BCG-unresponsive disease have been approved or reached late trials since 2020, an unprecedented pace for this stage.","Intravesical drug-releasing devices and gene therapies show that local delivery, not systemic drugs, is the frontier here."],"history":[{"year":1976,"title":"Morales reports intravesical BCG","refs":["bcg-and-intravesical-therapy"]},{"year":1990,"title":"BCG approved for carcinoma in situ of the bladder","refs":["bcg-and-intravesical-therapy"]},{"year":2020,"title":"Pembrolizumab approved for BCG-unresponsive carcinoma in situ","refs":["pembrolizumab"]},{"year":2022,"title":"Nadofaragene firadenovec: first gene therapy for bladder cancer","refs":["nadofaragene-firadenovec"]},{"year":2024,"title":"Nogapendekin alfa inbakicept with BCG approved","refs":["nogapendekin-alfa"]}],"pipeline":["tar-200","cretostimogene"],"openProblems":["Recurrent BCG shortages.","Predicting who will progress to muscle invasion.","The burden and cost of lifelong cystoscopy.","Comparing the new bladder-sparing options with each other and with cystectomy."],"parent":"urothelial"},"route":"/cancers/non-muscle-invasive-bladder-cancer/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"muscle-invasive-bladder-cancer","kind":"cancer","name":"Muscle-invasive and advanced bladder cancer","route":"/cancers/muscle-invasive-bladder-cancer/"},{"id":"urethral-urothelial-carcinoma","kind":"cancer","name":"Urothelial carcinoma of the urethra","route":"/cancers/urethral-urothelial-carcinoma/"}],"trial":[{"id":"nct06833073","kind":"trial","name":"A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)","route":"/trials/nct06833073/"},{"id":"nct07222488","kind":"trial","name":"A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)","route":"/trials/nct07222488/"},{"id":"nct06637423","kind":"trial","name":"A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)","route":"/trials/nct06637423/"},{"id":"nct05243550","kind":"trial","name":"A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer","route":"/trials/nct05243550/"},{"id":"nct06331299","kind":"trial","name":"A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer","route":"/trials/nct06331299/"},{"id":"nct06111235","kind":"trial","name":"A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT","route":"/trials/nct06111235/"},{"id":"nct07468851","kind":"trial","name":"A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy","route":"/trials/nct07468851/"},{"id":"nct02138734","kind":"trial","name":"A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer","route":"/trials/nct02138734/"},{"id":"nct07122414","kind":"trial","name":"A Study of Intravesical FL115 Alone or in Combination With BCG in Non-Muscle Invasive Bladder Cancer","route":"/trials/nct07122414/"},{"id":"nct07424287","kind":"trial","name":"A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC","route":"/trials/nct07424287/"},{"id":"nct04165317","kind":"trial","name":"A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer","route":"/trials/nct04165317/"},{"id":"nct07726992","kind":"trial","name":"A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC","route":"/trials/nct07726992/"},{"id":"nct06971614","kind":"trial","name":"A Study of T3011 in Patients With BCG-Unresponsive NMIBC or BCG-Exposed, Chemotherapy-Unresponsive NMIBC","route":"/trials/nct06971614/"},{"id":"hr-nmibc","kind":"trial","name":"A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)","route":"/trials/hr-nmibc/"},{"id":"nct06211764","kind":"trial","name":"A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)","route":"/trials/nct06211764/"},{"id":"nct06919965","kind":"trial","name":"A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer","route":"/trials/nct06919965/"},{"id":"nct06319820","kind":"trial","name":"A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer","route":"/trials/nct06319820/"},{"id":"nct06663137","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC","route":"/trials/nct06663137/"},{"id":"nct06545955","kind":"trial","name":"A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer","route":"/trials/nct06545955/"},{"id":"nct05943106","kind":"trial","name":"BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants","route":"/trials/nct05943106/"},{"id":"nct07480356","kind":"trial","name":"Efficacy and Safety of Intravesical TARA-002 Compared With Investigator's Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer","route":"/trials/nct07480356/"},{"id":"nct03711032","kind":"trial","name":"Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)","route":"/trials/nct03711032/"},{"id":"nct06995677","kind":"trial","name":"Efficacy and Safety of TYRA-300 in Participants With FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer","route":"/trials/nct06995677/"},{"id":"nct05037279","kind":"trial","name":"Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC)","route":"/trials/nct05037279/"},{"id":"nct03945162","kind":"trial","name":"Intravesical Photodynamic Therapy (\"PDT\") in BCG-Unresponsive/Intolerant Non-Muscle Invasive Bladder Cancer (\"NMIBC\") Patients","route":"/trials/nct03945162/"},{"id":"keynote-057","kind":"trial","name":"KEYNOTE-057","route":"/trials/keynote-057/"},{"id":"nct04752722","kind":"trial","name":"LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve","route":"/trials/nct04752722/"},{"id":"nct01310803","kind":"trial","name":"Multi-center Study to Evaluate the Efficacy and Safety of Maintenance Therapy With Valrubicin Versus no Maintenance, in Subjects Treated With Valrubicin Induction for Carcinoma in Situ (CIS) of the Bladder","route":"/trials/nct01310803/"},{"id":"nct06567743","kind":"trial","name":"Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC","route":"/trials/nct06567743/"},{"id":"nct06227065","kind":"trial","name":"Precise Chemoresection in Low-grade NMIBC Using Drug Screens in Patient-derived Organoids","route":"/trials/nct06227065/"},{"id":"nct05796375","kind":"trial","name":"Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance","route":"/trials/nct05796375/"},{"id":"nct05704244","kind":"trial","name":"Safety and Efficacy of FE 999326 Administered Intravesically to Japanese Subjects With High-grade, BCG Unresponsive, Non-muscle Invasive Bladder Cancer (NMIBC)","route":"/trials/nct05704244/"},{"id":"nct05951179","kind":"trial","name":"Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer","route":"/trials/nct05951179/"},{"id":"nct06732531","kind":"trial","name":"Safety, Tolerability, and Preliminary Efficacy of BH011 in Subjects With Non-Muscle-Invasive Bladder Cancer","route":"/trials/nct06732531/"},{"id":"nct07283835","kind":"trial","name":"Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin","route":"/trials/nct07283835/"},{"id":"nct06378242","kind":"trial","name":"To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2","route":"/trials/nct06378242/"},{"id":"nct06510374","kind":"trial","name":"Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer","route":"/trials/nct06510374/"}],"paper":[{"id":"paper-sylvester-eortc-risk-tables-eur-urol-2006","kind":"paper","name":"EORTC risk tables for recurrence and progression in Ta and T1 bladder cancer","route":"/key-papers/paper-sylvester-eortc-risk-tables-eur-urol-2006/"},{"id":"paper-eau-nmibc-guideline-eur-urol-2022","kind":"paper","name":"European Association of Urology guidelines on non-muscle-invasive bladder cancer (Ta, T1 and carcinoma in situ)","route":"/key-papers/paper-eau-nmibc-guideline-eur-urol-2022/"},{"id":"paper-keynote-057-lancet-oncol-2021","kind":"paper","name":"KEYNOTE-057: pembrolizumab for BCG-unresponsive non-muscle-invasive bladder cancer with carcinoma in situ","route":"/key-papers/paper-keynote-057-lancet-oncol-2021/"},{"id":"paper-nadofaragene-firadenovec-lancet-oncol-2021","kind":"paper","name":"Nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer","route":"/key-papers/paper-nadofaragene-firadenovec-lancet-oncol-2021/"}],"technology":[{"id":"bladder-epicheck","kind":"technology","name":"Bladder EpiCheck urine methylation test","route":"/technologies/bladder-epicheck/"},{"id":"hyperthermia-systems","kind":"technology","name":"Hyperthermia systems (BSD-2000, EHY-2000, superficial and interstitial applicators)","route":"/technologies/hyperthermia-systems/"},{"id":"bcg-and-intravesical-therapy","kind":"technology","name":"Intravesical therapy (BCG, chemotherapy, devices, gene and viral therapy)","route":"/technologies/bcg-and-intravesical-therapy/"},{"id":"photodynamic-therapy-lasers","kind":"technology","name":"Photodynamic therapy lasers and light sources","route":"/technologies/photodynamic-therapy-lasers/"},{"id":"urine-bladder-cancer-tests","kind":"technology","name":"Urine tests for bladder cancer (cytology, FISH, RNA and methylation)","route":"/technologies/urine-bladder-cancer-tests/"}],"drug":[{"id":"cretostimogene","kind":"drug","name":"Cretostimogene grenadenorepvec","route":"/drugs/cretostimogene/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"tar-200","kind":"drug","name":"Gemcitabine intravesical system (TAR-200)","route":"/drugs/tar-200/"},{"id":"mitomycin","kind":"drug","name":"Mitomycin C","route":"/drugs/mitomycin/"},{"id":"nadofaragene-firadenovec","kind":"drug","name":"Nadofaragene firadenovec","route":"/drugs/nadofaragene-firadenovec/"},{"id":"nogapendekin-alfa","kind":"drug","name":"Nogapendekin alfa inbakicept","route":"/drugs/nogapendekin-alfa/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"term":[{"id":"cystectomy","kind":"term","name":"Radical cystectomy","route":"/terms/cystectomy/"}],"person":[{"id":"stephen-boorjian","kind":"person","name":"Stephen A. Boorjian","route":"/people/stephen-boorjian/"}]}}