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AVZO-103 is a Nectin-4/TROP2 biospecific antibody-drug conjugate for adult patients with urothelial carcinoma whose tumors have progressed on enfortumab vedotin.

The approval is supported by results from the phase 3 KEYNOTE-905/EV-303 trial.

Notably, 81% of patients said that they were interested in trying new or different treatment options.

The CxBladder Triage Plus Test identifies patients with hematuria who are at higher risk for urothelial carcinoma.

John Eifler, MD, highlights new real-world evidence on nadofaragene firadenovec-vncg for BCG-unresponsive NMIBC.

Mobley also shares her treatment approach to BPH and explains the challenges of treating OAB.

"I'm very excited to bring this therapy to our patients in the Philadelphia area and to be able to offer it at MidLantic," says David Cahn, DO, MBS, FACOS.

"For me and the patients, [nadofaragene firadenovec is] a very convenient dosing schedule, and it's a very efficacious treatment," says Ravi D. Chauhan, MD, FACS.

Suzanne Merrill, MD, outlines recent progress with immunotherapy across NMIBC and MIBC.

The FDA has confirmed that results from the UTOPIA trial can support submission of an NDA for UGN-103.

The study is assessing FL115 in combination with BCG in patients with non-muscle invasive bladder cancer.

Liu notes that current data—showing a response rate of just over 50%—indicate that the BCG-unresponsive CIS cohort is the most appropriate initial target population.


A recap of the FDA submissions and regulatory decisions in urology from October 2025.

Explore the evolving landscape of non-muscle invasive bladder cancer treatments, focusing on the promising gene therapy detalimogene voraplasmid and its trial results.

Petros Grivas, MD, PhD, touches on the signficance of KEYNOTE-905 data, which were presented at ESMO 2025.

Christof Vulsteke, MD, PhD, discusses results from the KEYNOTE-905 trial, evaluating perioperative EV/pembrolizumab in cisplatin-ineligible MIBC.

According to the authors, immune-mediated adverse events were manageable and consistent with the known profiles for ICIs.

The code, J9282, will be effective on January 1, 2026.

Three cycles of chemotherapy was shown to improve patient-reported outcomes vs six cycles, with no detriment to overall survival.

The findings revealed that patients prioritized improvements in overall survival and reductions in cancer recurrence at 5 years over all other treatment factors

The PDUFA target action date for the application is April 7, 2026.


In patients who were ctDNA positive, median DFS was 9.9 months (95% CI: 7.2-12.7) in the atezolizumab group vs 4.8 months (95% CI: 4.1-8.3) in the placebo group.

Enrique Grande, MD, shares key findings from the DISCUS trial, exploring 3 vs 6 cycles of platinum-based chemotherapy for advanced urothelial carcinoma.












































