Bladder Cancer

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.

Panelists discuss how non–muscle-invasive bladder cancer (NMIBC) is staged, graded, and treated according to risk stratification, with detailed explanations of low-, intermediate-, and high-risk categories and corresponding treatment pathways.

“The key finding is [that] this might be, in itself, a novel risk factor for bladder cancer," says Laura E. Davis, MD.

"The use of telemedicine is heavily dependent on supportive legislature," write Tracey L. Krupski, MD, and Jeunice Owens-Walton, MD.

The phase 3 RC48-C016 trial met its primary end points.

The study was published in JCO Oncology Practice.

The data are to be presented at an upcoming medical conference.

The CR rate was 71% in patients with BCG-unresponsive NMIBC with CIS with or without papillary disease.

Data showed that physical function and self-reported frailty assessments were poorly correlated.

The Oncologic Drugs Advisory Committee meeting is scheduled for May 21, 2025.

"It’s a very good time to be taking care of patients with bladder cancer," says Joshua J. Meeks, MD, PhD.

“In this well-selected patient population, it is possible to treat with systemic therapy alone," says John L. Gore, MD, MS.

“[These are] very good numbers for these patients who otherwise would undergo a radical cystectomy," says Félix Guerrero-Ramos, MD, PhD, FEBU.

The sBLA for NAI was submitted to the FDA in March 2025.

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

“It's going to be an important time for US urologists to identify that this is becoming the standard of care," says Joshua J. Meeks, MD, PhD.