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%.

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

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.

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.

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

One key approach is to increase the representation of women on editorial boards of journals and as reviewers.

The objectives of the trial are to further confirm the recommended phase 2 dose and to assess the efficacy of MVR-T3011.

"As urologists, we are the gatekeepers, and we must always perform the best possible surgery to optimize oncological outcomes," writes Jeremy Teoh, MBBS, FRCSEd (Urol), FCSHK, FHKAM (Surgery).

Panelists discuss how to approach treatment for a younger (49-year-old) male veteran with bladder cancer, focusing on the rising rates among veterans, challenges with recurrent disease despite BCG therapy, various second- and third-line treatment options, including gemcitabine-docetaxel combination therapy and the importance of thorough monitoring for disease progression.

Results of an exclusive Urology Times survey point to urologists preferring intravesical chemotherapy for treating BCG-unresponsive NMIBC.

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

Panelists discuss how to manage the treatment of a 68-year-old woman with painless intermittent hematuria and positive cytology for high-grade urothelial cancer, addressing gender differences in diagnosis timing, the importance of repeat transurethral resection (TURBT) procedures, BCG therapy options, and considerations for radical cystectomy with pelvic organ preservation when BCG fails.

The findings also lend further credence to the muscle-invasive bladder cancer treatment regimen, investigators reported.

"The pre-specified thresholds for statistical significance were not met for the dual primary end points of overall survival in cisplatin-ineligible and PD-L1 positive patients," said Michiel Van der Heijden, MD, PhD.

"There was activity across all the groups from an EFS perspective," said Thomas B. Powles, MBBS, MRCP, MD.

Vitaly Margulis, MD, reported an overall response rate of 86.5%, and a complete response rate of 73%.

Campbell emphasized that although gender representation in medicine is shifting, structural and cultural biases continue to influence academic recognition.

Panelists discuss how they approach a typical bladder cancer case of a 79-year-old man with hematuria, including initial diagnostic procedures, the importance of proper tumor measurement during resection, BCG therapy protocols, and management options for BCG-unresponsive disease with a focus on nadofaragene firadenovec (Adstiladrin).

The committee voted 4-5 in opposition of a favorable benefit-risk profile.

The bladder transplant procedure involved a collaboration between the University of California, Los Angeles and the University of Southern California.