Bladder Cancer

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.

"Viral vectors are basically a blueprint of the virus that's used to carry the DNA payload into the target tissue, but the problem is they have some issues," says Katherine Chan, MD, MPH.

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

John A. Taylor, III, MD, MS, discussed the new wealth of options in non–muscle invasive bladder cancer, specifically highlighting detalimogene voraplasmid.

“One important aspect to get across…is that access to this EAP is pretty easy," says Suzanne B. Merrill, MD, FACS.

"The striking CR rates observed in these early cohorts are highly encouraging, particularly for BCG-unresponsive NMIBC patients who currently have limited treatment options," says Paul D. Anderson, MBBS, FRACS.

"Provided that we will confirm the efficacy data long-term, there is an opportunity to spare, de-escalate a bit, the treatment in select patients, and to expose the patient with inferior risk of developing severe [adverse] effects," says Andrea Necchi, MD.

In patients with intermediate-risk disease, 4 of 5 patients demonstrated a complete response.

“High risk, non–muscle invasive bladder cancer carries a significant risk of recurrence and progression. This emphasizes the need for careful patient selection, especially when we are considering bladder-sparing approaches," says Neeraja Tillu, MD.

"Now with the new translational data indicating that post-treatment close contact precautions are unnecessary, I am confident that cretostimogene will represent a breakthrough in bladder cancer treatment, if approved by the FDA," says Trinity J. Bivalacqua, MD, PhD.

"There is evidence for a direct link between the exposures you get by doing your job as a firefighter and then developing cancer down the road," says Sima P. Porten, MD, MPH.