AUA/SUO Issue 2026 Update to Non–Muscle Invasive Bladder Cancer Guideline

The American Urological Association (AUA), in partnership with the Society of Urologic Oncology (SUO), released the 2026 amendment to its non–muscle invasive bladder cancer (NMIBC) guideline, the AUA announced. NMIBC accounts for approximately 80% of the estimated 84,530 new bladder cancer cases expected in the US in 2026, and the amended guideline adds 40 statements on risk stratification, pathologic terminology, biomarkers, surveillance, and treatment, reflecting a literature review through December 2025.^1,2

“As the treatment landscape for [NMIBC] continues to evolve, it is essential that clinical guidance reflects the latest evidence,” said Peter E. Clark, MD, chair of the guideline, in a news release.¹ “This amendment provides clinicians with practical recommendations that support individualized decision-making while addressing emerging therapeutic approaches and ongoing advances in the field.”

Risk Stratification and Surveillance

The guideline directs clinicians to assign a clinical stage and classify patients as low, intermediate, or high risk at each occurrence or recurrence, though it acknowledged the lack of high-grade evidence for risk stratification affecting recurrence, progression, or survival.² Updated risk-adjusted surveillance and follow-up intervals are specified for each risk category, including cystoscopy timing and, for intermediate- or high-risk patients, upper tract imaging at 1- to 2-year intervals.

Bladder-Preserving Options for Recurrent Low-Grade Disease

For patients with recurrent low-grade NMIBC, the guideline states that clinicians may perform transurethral resection or fulguration, use an intravesical chemoablative agent, or manage the patient with active surveillance. For patients with a history of low-grade Ta disease who experience a small papillary recurrence, clinicians may offer surveillance and/or in-office fulguration or chemoablation as an alternative to transurethral resection under anesthesia. The guideline cites intravesical chemoablation trials, including that of UGN-102, that have reported complete response rates of up to 80% and a pooled complete response rate of 50.9% across studied agents in a recent meta-analysis, with the principal benefit framed as reducing repeat surgical interventions rather than direct efficacy comparison with transurethral resection.³

Managing High-Risk Disease Involving the Prostatic Urethra

The amendment addresses management of high-risk NMIBC involving the prostatic urethra, an involvement associated with worse cancer-specific outcomes. For patients who decline radical cystectomy and choose intravesical therapy, the guideline states that clinicians should perform a repeat transurethral resection of the prostatic urethra to improve staging accuracy and optimize subsequent intravesical therapy efficacy. The guideline notes that reported complete response rates with transurethral resection of the prostate followed by intravesical therapy have ranged from 48% to 86.6% across prior research.⁴

Urinary Biomarkers

The guideline states that clinicians should not use urinary biomarkers in place of cystoscopic evaluation during NMIBC surveillance and should not routinely use a urinary biomarker or cytology during surveillance in patients with low-risk cancer and normal cystoscopy.² Clinicians may use biomarkers to assess and predict response to intravesical therapy and to adjudicate equivocal cytology. When discussing future directions, the guideline acknowledged the potential of third-generation assays to reduce the number of cystoscopies, as was seen in the DaBlacCa-15 trial (NCT03348969)⁵ but noted the continuing variability of biomarker assays and suggested that digital pathology and artificial intelligence could improve their reliability.

Emerging Therapies for BCG-Unresponsive Disease

The amendment considers newly published research on therapies for Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC. It cites TAR-200 (Inlexzo), a gemcitabine intravesical drug-releasing system, which in the SunRISe-1 study (NCT04640623) demonstrated a 78.8% complete response rate at 3 months and 45.9% durability of complete response at 1 year among patients with BCG-unresponsive disease.⁶

It also describes sequential intravesical gemcitabine and docetaxel as an alternative for BCG-unresponsive high-grade disease, citing a retrospective multicenter study of 299 patients that found improved cancer-specific survival, progression-free survival, and freedom from cystectomy with gemcitabine/docetaxel compared with additional BCG.⁷ The guideline notes that additional investigational agents in the BCG-unresponsive space, none yet FDA approved, include EG-70 (detalimogene voraplasmid) in the LEGEND trial (NCT04752722) and cretostimogene grenadenorepvec in the BOND-003 (NCT04452591) and CORE-001 (NCT04387461) trials.

“The field of [NMIBC] continues to evolve rapidly, with new therapies and management approaches expanding options for patients and clinicians,” said Adam S. Kibel, MD, SUO president, in a news release. “These updated recommendations reflect the latest evidence and underscore the importance of individualized, risk-based care. By incorporating emerging research and practical treatment strategies, this guideline will help urologists make informed decisions that optimize patient outcomes.”¹

REFERENCES

1. American Urological Association Releases Non-Muscle Invasive Bladder Cancer Guideline Amendment. News release. American Urological Association. September 3, 2026. Accessed September 4, 2026. https://tinyurl.com/mvckkske

2. Clark PE, Holzbeierlein J, Chang SS, et al. 2026 updates to the diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. J Urol. Published online September 3, 2026. doi:10.1097/JU.0000000000005280

3. Li R, Hensley PJ, Babjuk M, et al. Intermediate-risk Non-muscle-invasive Bladder Cancer: Recommendations for Definitions, Risk Stratification, Management Strategies, and Clinical Trial Design from the International Bladder Cancer Group. Eur Urol Oncol. 2025;8(6):1685-1695. doi:10.1016/j.euo.2025.08.003

4. Ingram JW, Chung R, Laplaca C, McKiernan JM, Lenis AT, Anderson CB. Incidence and management of prostatic urethra recurrence in a cohort of 21 patients who received BCG induction for non-muscle invasive bladder cancer. Urol Oncol. 2024;42(9):290.e11-290.e16. doi:10.1016/j.urolonc.2024.04.017

5. Lindgren MS, Hansen E, Azawi N, Nielsen AM, Dyrskjøt L, Jensen JB. DaBlaCa-13 Study: Oncological Outcome of Short-Term, Intensive Chemoresection With Mitomycin in Nonmuscle Invasive Bladder Cancer: Primary Outcome of a Randomized Controlled Trial. J Clin Oncol. 2023;41(2):206-211. doi:10.1200/JCO.22.00470

6. Jacob JM, Guerrero-Ramos F, Necchi A, et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guerin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. Presented at: American Urological Association Annual Congress; April 26-29, 2025; Las Vegas, NV. P2s.

7. Tan WS, McElree IM, Davaro F, et al. Sequential Intravesical Gemcitabine and Docetaxel is an Alternative to Bacillus Calmette-Guérin for the Treatment of Intermediate-risk Non-muscle-invasive Bladder Cancer. Eur Urol Oncol. 2023;6(5):531-534. doi:10.1016/j.euo.2023.06.011