Bladder Cancer

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

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%.

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.

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

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.

“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.

The study population was able to avoid 952 cystoscopies and 70 CT scans, according to the investigators.

In cohort A, the cystectomy-free rate at 36 months was 84%.

"I would argue that UGN-102 may very well represent a well-tolerated alternative to TURBT as primary treatment for patients with low-grade disease,” says Sandip M. Prasad, MD, MPhil.

Joseph Jacob, MD, outlines key findings on TAR-200 monotherapy from cohort 2 of the SunRISe-1 study.

The investigators reported that the median Kaplan-Meier estimate of DOR was 24.2 months.

"97% [of patients] remain progression free, and 84.5% avoided cystectomy, highlighting cretostimogene’s bladder-sparing potential,” said Mark D. Tyson II, MD, MPH.

“In the patients with CIS, the probability of a continued complete response at 36 months was 92% vs 67.7%," said Neal D. Shore, MD, FACS.

Treatment with TARA-002 was associated with a 100% high-grade CR at any time in BCG-unresponsive participants.

Matthew D. Galsky, MD, discusses how urologists should approach patient selection for perioperative durvalumab plus chemotherapy based on eligibility criteria for the NIAGARA trial.

Treatment with nadofaragene led to a complete response rate of 75% at 3 months.

We preview several noteworthy P2 presentations in the urologic oncology space.

Merrill discusses the evolving non–muscle invasive bladder cancer treatment space.