Top 10 Urology Times bladder cancer articles of 2025

Urology Times’® top bladder cancer stories of 2025 reflected the wave of innovation across the field, from emerging combinations in the BCG-naïve setting to the growing set of options for patients with BCG-unresponsive disease. Other key topics that captured our audiences’ attention included survey results on the uptake of novel agents in non–muscle invasive bladder cancer (NMIBC) as well as an editorial on the financial considerations for new therapies, highlighting the questions urologists now face as they adapt to an expanding arsenal of treatment options.

Anktiva as a lymphocyte rescue molecule: Unlocking the power of NK cells and T cells

In this interview, Patrick Soon-Shiong, MD, discusses the mechanism of action for nogapendekin alfa inbakicept-pmln (Anktiva), which was approved by the FDA in April 2024 for patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. Soon-Shiong also touches on ongoing studies of the agent across other disease settings, such as in patients with papillary-only NMIBC.

FDA approves mitomycin intravesical solution for recurrent LG-IR-NMIBC

On June 12, 2025, the FDA approved mitomycin for intravesical solution (Zusduri; formerly UGN-102) for the treatment of adult patients with recurrent low-grade intermediate-risk NMIBC (LG-IR-NMIBC).¹ The approval was primarily supported by findings from the phase 3 ENVISION trial (NCT05243550), which met its primary end point by demonstrating a 78% (95% CI, 72 to 83) complete response (CR) rate in patients at 3 months following the first instillation of the therapy.

FDA approves gemcitabine intravesical system for BCG-unresponsive NMIBC

On September 9, 2025, the FDA approved the gemcitabine intravesical system (Inlexzo; formerly TAR-200) for adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors.² The determination was based on data from cohort 2 of the phase 2b SunRISe-1 trial (NCT04640623), which showed a CR rate of 82% (95% CI, 72 to 90) in this patient population. Further, 51% of patients remained in CR for at least 1 year.

Real-world outcomes with nadofaragene point to safety, efficacy of NMIBC treatment

The first reporting of real-world data for nadofaragene firadenovec-vncg (Adstiladrin) indicated that the treatment yielded positive efficacy and safety outcomes in patients with NMIBC. The results were presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, California.³

DISCUS trial shows improved PROs with de-escalation of chemotherapy in mUC

Initial results from the phase 2 DISCUS trial (NCT06892860) showed that patients with locally advanced or metastatic urothelial carcinoma who received 3 cycles of platinum-based chemotherapy before maintenance avelumab experienced significantly better quality-of-life outcomes compared with those receiving 6 cycles, without compromising overall survival.⁴ The results, which were presented at the 2025 European Society for Medical Oncology Congress in Berlin, Germany, support chemotherapy de-escalation as a feasible strategy for these patients.

CMS issues permanent J code for mitomycin for intravesical solution for LG-IR-NMIBC

The Centers for Medicare & Medicaid Services (CMS) issued a permanent Healthcare Common Procedure Coding System (HCPCS) Level II J Code for mitomycin for intravesical solution for patients with recurrent LG-IR-NMIBC.⁵ The code, J9282, will become effective on January 1, 2026.

Survey: New NMIBC treatments face slow uptake

An exclusive Urology Times survey examined urologists' treatment patterns and preferences for BCG-unresponsive NMIBC, providing valuable insights into current practices. Overall, the findings pointed to a preference for intravesical chemotherapy over newer agents.

FDA approves expanded access program to provide alternative source of BCG

In February 2025, the FDA authorized an expanded access program to provide recombinant BCG (rBCG) to patients across the US.⁶ According to ImmunityBio, the hope is that this program would help to address the ongoing shortage of TICE BCG in the US.

The economics of bladder cancer in the US: Increasing costs and unsustainable patterns

In this editorial, Urology Times’ co-editor in chief, Michael Cookson, MD, MMHC, FACS, emphasized that while therapeutic innovation in bladder cancer has led to meaningful clinical advances, it has also intensified the already substantial financial burden of one of the most expensive cancers to treat. Cookson calls for a shift toward value-based, individualized care that balances innovation with cost-effectiveness, emphasizing better patient selection, comparative effectiveness research, and payment reform to ensure long-term sustainability.

BCG/ICI combinations offer potential paradigm shift in BCG-naïve NMIBC

In an interview with Urology Times, Tom Jayram, MD, a urologic oncologist at Urology Associates in Nashville, Tennessee, discussed the evolving treatment landscape for BCG-naïve NMIBC. He highlighted emerging regimens evaluating immune checkpoint inhibitors in combination with BCG, with a focus on ongoing trials such as CREST, POTOMAC, and ALBAN.

REFERENCES

1. FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. News release. US Food & Drug Administration. June 12, 2025. Accessed December 29, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-intravesical-solution-recurrent-low-grade-intermediate-risk-non-muscle

2. U.S. FDA approval of INLEXZO (gemcitabine intravesical system) set to transform how certain bladder cancers are treated. News release. Johnson & Johnson. September 9, 2025. Accessed December 29, 2025. https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated

3. Moyer JA, Durant A, Nguyen M, et al. Real-world outcomes of nadofaragene firadenovec in BCG-unresponsive non-muscle invasive bladder cancer. J Clin Oncol. 2025;43(suppl 5). Abstract 70. doi:10.1200/JCO.2025.43.5_suppl.716

4. Grande E, Hussain SA, Duran MAC, et al. DISCUS: A phase II study comparing 3 vs 6 cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cancer. Presented at: 2025 European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. LBA109. https://s3.eu-central-1.amazonaws.com/m-anage.com.storage.esmo/static/esmo2025_abstracts/LBA109.html.pdf

5. Centers for Medicare and Medicaid Services assigns permanent J code for ZUSDURI™ effective January 1, 2026. News release. UroGen. October 27, 2025. Accessed December 29, 2025. https://investors.urogen.com/news-releases/news-release-details/centers-medicare-and-medicaid-services-assigns-permanent-j-code

6. FDA authorizes ImmunityBio to provide recombinant BCG (rBCG) to urologists to address TICE BCG shortage. News release. ImmunityBio. February 19, 2025. Accessed December 29, 2025. https://ir.immunitybio.com/news-releases/news-release-details/fda-authorizes-immunitybio-provide-recombinant-bcg-rbcg