Bladder Cancer

In the phase 3 RC48-C016 study, disitamab vedotin plus toripalimab significantly improved PFS and OS vs chemotherapy.

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.

From a practical standpoint, integrating ctDNA into clinical practice poses challenges.

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

Katherine Chan, MD, MPH, details the design of the pivotal phase 1/2 LEGEND trial, assessing the safety and efficacy of detalimogene voraplasmid in 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.

Ultimately, the take-home message for practicing urologists is to apply TMT judiciously, taking into account the patient's clinical profile, personal values, and financial situation.

Betty Wang, MD, said she envisions ctDNA integrating into existing surveillance protocols for patients with high-risk NMIBC.

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.

Wang and Bukavina outline several cases of ctDNA's utility in the space.

“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 Daniel D. Joyce, MD, MS, policy initiatives should focus on improving the value and efficiency of radiation.

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.