Bladder Cancer

In this interview, Tom Jayram, MD, offers insights into how BCG plus immune checkpoint inhibitors may redefine the treatment landscape in BCG-naïve NMIBC.

A phase 3 registrational trial of NDV-01 is expected in the first half of 2026.

Take a look through key stories from last month, including regulatory news, trial updates, and other practice-changing advancements.

FX-909 is an investigational small molecule PPARG inhibitor for patients with locally advanced or metastatic urothelial carcinoma.

Treatment with mitomycin for intravesical solution led to a 24-month DOR of 72.2% among patients who achieved an initial complete response.

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

Data show that TAR-200 monotherapy led to high complete response rates and encouraging DFS in patients with BCG-unresponsive high-risk NMIBC.

Data from the phase 3b study were recently published in Reviews in Urology, showing that administration of mitomycin intravesical solution in the home setting was feasible, safe, and effective.

Mitomycin intravesical solution was granted FDA approval in June 2025 for recurrent LG-IR-NMIBC.

Take a look back through some of the top stories from the first half of the year.

The new drug application for TAR-200 is supported by data from cohort 2 of the phase 2b SunRISe-1 trial.

The Continuity Grant will support projects in bladder cancer and/or upper tract urothelial carcinoma that were previously scientifically reviewed, approved, and funded.

Alpha1H was granted a fast track designation in November 2023.

“This study adds to the growing body of evidence supporting combination intravesical chemotherapy as a feasible option even after prior treatment failure," says Ian M. McElree, MD.

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.

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.