Bladder Cancer

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.

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.

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.

Two recent Clinical Forum discussions sought to examine how emerging therapeutic options and evolving treatment standards in non–muscle invasive bladder cancer affect clinical practices and patient outcomes.

Three recent expert-led Clinical Forums explored current challenges and advancements in the management of non–muscle invasive bladder cancer.

"There really wasn't a difference in in surgical outcomes. The patients tolerated it very well,” says Joshua J. Meeks, MD, PhD.

The sBLA is supported by data from cohort B of the pivotal QUILT-3.032 trial.

Sima P. Porten, MD, MPH, discusses the need to better understand how genetic makeup influences how individuals process environmental toxins.

“I feel a lot of providers, with Antiva being available, have unfortunately reserved use of this great FDA-approved agent for BCG-unresponsive patients because of the supply issue with BCG," says Suzanne B. Merrill, MD, FACS.

Betty Wang, MD, provides insight on 3 presentations that she believes “may be game changing” in urology.

“The NIAGARA approval really begins to bring immunotherapy into the neoadjuvant setting," says Joshua J. Meeks, MD, PhD.

A lookahead of the notable FDA decisions and conferences slated for Q2 2025.

"This is another tool in our armamentarium to treat muscle-invasive bladder cancer and represents an advance compared to where we've been over the past few decades," says Matthew D. Galsky, MD.

"They are risking their own lives for their job, so it's the part of the whole community to do our best to try to keep them safe," says Sima P. Porten, MD, MPH.

"We must lobby to maintain our current funding levels and push for increased support to continue driving progress in cancer care," says Michael S. Cookson, MD, MMHC, FACS.

“If it is as efficacious as it looks, we will have more patients who are getting effective standard of care treatment, not needing to go on to further treatment, not having recurrences, [having decreased] morbidity from repeated resections, and saving bladders in the process," says Eugene B. Cone, MD.

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

The European Commission must issue a decision on the application on or by June 2, 2025.

"I'm all for this great effort by ImmunityBio to provide us with an alternative option,” says Suzanne B. Merrill, MD, FACS.

The approval is supported by results from the phase 3 NIAGARA trial.