Bladder Cancer

According to the company, the MHRA approval represents the first marketing approval outside the US for NAI.

Eligible patients will receive UGN-103 75 mg intravesically once per week for 6 weeks.

The data, collected as part of the phase 1/2 Duravelo-1 trial, showed an objective response rate of 65%.

Anne K. Schuckman, MD, discusses some of the current challenges in delivering optimal care for patients with non–muscle invasive bladder cancer.

Findings indicated that although trimodal therapy improved the quality of life for patients with muscle-invasive bladder cancer compared with cystectomy, its significantly higher cost made it not cost-effective.

Take a look through all the regulatory milestones in urology from the first half of the 2025.

A notable finding was that 35% of these NMIBC patients exhibited ctDNA positivity.

Catch up on exclusive videos you may have missed from the first half of the year.

Here’s a look back at notable news between April and June 2025.

In this video, part 5 in a 5-part series, panelists examine the economic and logistical realities of bringing mitomycin for intravesical solution (Zusduri; formerly UGN-102) into private practice.

In this video, part 4 in a 5-part series, Nick Liu, MD, outlines key scenarios where surgical resection remains preferred for treating LG-IR-NMIBC.

In this video, part 3 in a 5-part series, panelists discuss the long-term clinical impact and health care system implications of mitomycin for intravesical solution (Zusduri; formerly UGN-102).

In this video, part 2 in a 5-part series, Nick Liu, MD, breaks down the formulation behind mitomycin for intravesical solution (Zusduri; formerly UGN-102).

In this video, part 1 in a 5-part series, panelists discuss how mitomycin for intravesical solution (formerly UGN-102, now marketed as Zusduri) fits into the evolving management landscape for recurrent bladder tumors.

Vignesh T. Packiam, MD, outlines the mechanism of action for detalimogene voraplasmid as well as its potential benefits in terms of storage and dosing.

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

The TOBY test works by analyzing the molecular signatures of volatile organic compounds in urine.

The primary end point for the trial is the complete response rate at 3 months.

A comprehensive guide to the key regulatory decisions and conferences slated for Q3 of 2025.

Detalimogene is currently under evaluation in the pivotal phase 1/2 LEGEND trial.

Anne Schuckman, MD, on optimal sequencing strategies, the SWOG 1602 trial, and the emerging role of ctDNA.

Anne K. Schuckman, MD, describes the growing number of options in NMIBC and the impact of these therapies on clinical practice.

The CHAI biomarker was shown to outperform EAU and AUA stratifications.

"At the end of the day, it's going to be unlikely that we're going to use a single therapy for all of our patients," says Vignesh T. Packiam, MD.

The approval is supported by findings from the phase 3 ENVISION trial.