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Articles

Overall, 71% of patients had no fragment greater than 2 mm following treatment.

BWL plus ultrasonic propulsion shows safety, efficacy for small renal stones

“We are witnessing the dawn of teletreatment,” says Jihad Kaouk, MD, FACS. 

Urologists perform first remote robot-assisted HIFU for prostate cancer

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.

NMIBC Clinical Forums highlight novel therapies and treatment strategies

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

Exploring new avenues in non–muscle invasive bladder cancer treatment

The bladder cancer section is a comprehensive resource for urology news and expert insights. Read more at Urology Times.

Bladder Cancer | Urology News & Expert Insights | Urology Times

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Clinical Focus

Leonard G. Gomella, MD, FACS; Maha Hussain, MD, FACP, FASCO; Daniel P. Petrylak, MD

18th Annual Interdisciplinary Prostate Cancer Congress® and Other Genitourinary Malignancies

 highlights the state of bladder cancer care in recognition of Bladder Cancer Awareness Month this May. During the discussion he touches on his own clinical practice, recent advances in the field, data on bladder cancer presented at the recent AUA meeting, including his own study, "Mental health illness in patients with non-muscle invasive bladder cancer. Does BCG play a role?", and more. 

Kamat is a professor of urologic oncology at University of Texas MD Anderson Cancer Center in Houston. 

Don’t forget to subscribe to Speaking of Urology® on 

, or anywhere that podcasts are available.

In this episode, Ashish M. Kamat, MD, MBBS, highlights the state of bladder cancer care in recognition of Bladder Cancer Awareness Month. 

Bladder Cancer Awareness Month: Dr. Kamat highlights the state of bladder cancer care

® Assistant Editor Janelle Hart spoke with 

They give an overview of the app they co-created, BlaTUR, which was designed to help clinicians risk stratify their patients and manage their practices more efficiently. Ritch is an associate professor of urology and associate director of UHealth International, and Katz is a PGY5 resident at the Miller School of Medicine, University of Miami, Florida.

“It's not a replacement for clinical judgment, obviously. But at the end of the day, the idea is that it shows you what your next steps are based on what the American Urological Association and [Society of Urologic Oncology] guidelines are for non-muscle invasive bladder cancer,” Chad R. Ritch, MD, MBA, FACS.

Speaking of Urology Podcast: Dr. Ritch and Dr. Katz discuss new bladder cancer management app

He discusses the current state of the BCG shortage, what is being done to resolve it, and what the future holds for patients with non–muscle-invasive bladder cancer who are seeking treatment. Chang is a Patricia and Rodes Hart professor of urology and oncology at the Vanderbilt University Medical Center and chief surgical officer at the Vanderbilt Ingram Cancer Center, Vanderbilt University, Nashville, Tennessee.

“I wouldn't be surprised if we have spotty distribution areas of concern for the next several years,” says Sam S. Chang MD, MBA, on the latest episode of the UT podcast Speaking of Urology. 

What does the BCG shortage look like in 2021?

 paper, “A 30-Year Review of Cystectomy Litigation,” for which she served as senior author. The paper, Malik says, “is a snapshot into what we can find about malpractice associated with cystectomy.” Malik is an assistant professor and director of female pelvic medicine and reconstructive surgery at the University of Maryland Medical System, Baltimore.

A search of a legal database found 42 cases related to cystectomy over a 30-year period.

Dr. Rena Malik on cystectomy-related litigation

 discusses findings from a paper published in Urology titled, Comparing Costs of Radical Versus Partial Cystectomy for Patients Diagnosed With Localized Muscle-Invasive Bladder Cancer: Understanding the Value of Surgical Care, for which he served as a study author. Williams is chief of urology and professor of urology and radiology at the University of Texas Medical Branch at Galveston.

Williams discusses a study comparing costs for radical versus partial cystectomy.

Dr. Stephen Williams on costs of surgical treatments for bladder cancer

In this episode, Angela B. Smith, MD, MS, of UNC Lineberger Comprehensive Cancer Center, discusses the recent FDA approval of Jelmyto, which is the first therapy for the treatment of low-grade upper tract urothelial cancer.

Speaking of Urology podcast: Dr. Angela Smith discusses Jelmyto for low-grade UTUC

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

FDA approval sought for Anktiva in papillary NMIBC

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

What urologists can expect in Q2 of 2025 

"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.

The importance of federal funding in cancer research: A call to action

Expanded access programs (EAPs), such as a recently FDA-authorized EAP in which ImmunityBio is partnering with the Serum Institute of India to provide recombinant BCG (rBCG), are “wonderful opportunities” to open up access to needed medications, according to Suzanne B. Merrill, MD, FACS.

“The Tice BCG shortage is a great example of where we needed an EAP, and now we have one with using what looks like a comparable alternative to our standard of care,” said Merrill, a urologic oncologist with Colorado Urology in Lone Tree.

Merrill said her practice is looking forward to participating in the EAP for rBCG.

“I will tell you, in our practice, we are actually in the process of getting set up for this EAP, and we're really excited to be able to use it for our patients,” she commented.

Suzanne B. Merrill, MD, FACS, discusses the evolving non–muscle invasive bladder cancer treatment space

Suzanne B. Merrill, MD, FACS, discusses rBCG and the NMIBC landscape

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

“The landscape for available drugs is just rapidly expanding in non–muscle invasive bladder cancer, and we’re finally catching up to this unmet need of having all not really many alternatives at all for our patients with non–muscle invasive bladder cancer. [What we have found is] stimulating the immune system appears to be key in helping to control this disease and so using viral agents [makes] sense. We know that is 1 way to stimulate the immune response. It is a challenging situation. A lot of new agents that are coming down the pipeline are viral agents, but there are also some, non-viral agents coming down as well as some new delivery systems, of course, with chemotherapy. We're going to have to see how it plays out, because certainly manufacturing biologic drugs definitely poses a challenge for sustainability,” Merrill said.

1. FDA authorizes ImmunityBio to provide recombinant BCG (rBCG) to urologists to address TICE BCG shortage. News release. ImmunityBio. February 19, 2025. Accessed February 19, 2025. https://ir.immunitybio.com/news-releases/news-release-details/fda-authorizes-immunitybio-provide-recombinant-bcg-rbcg

Videos

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

One of the top stories in urology in the first quarter of 2025 was the FDA’s approval of neoadjuvant durvalumab (Imfinzi) in combination with gemcitabine and cisplatin, followed by adjuvant durvalumab monotherapy following radical cystectomy, for adult patients with muscle invasive bladder cancer (MIBC).

Joshua J. Meeks, MD, PhD, was asked about what practical considerations, such as infusion scheduling, monitoring for immune-related adverse events, and patient education, will be important to implement when incorporating this new treatment paradigm into routine clinical practice.

“From a urology perspective, I don't think we're going to see any difference,” said Meeks, an associate professor of urology at Northwestern University Feinberg School of Medicine in Chicago, Illinois and an investigator on the NIAGARA trial evaluating the treatment regimen.

“Jim Catto [MB ChB, PhD, FRCS(Urol)], presented the surgical data at EAU, and that data look great. There were no significant delays in time to surgery. There really wasn't a difference in in surgical outcomes. The patients tolerated it very well,” Meeks added.

Joshua J. Meeks, MD, PhD, discusses the approval of neoadjuvant durvalumab (Imfinzi) in combination with gemcitabine and cisplatin, followed by adjuvant durvalumab monotherapy following radical cystectomy

Expert describes implications of neoadjuvant durvalumab approval in MIBC

Meeks was also asked for his thoughts on the long-term efficacy and safety of the treatment regimen.

“For muscle-invasive bladder cancer, what we really look at is a 2-year window after surgery. If you look at all of our surveillance regimens, as far as imaging and any kind of urine biomarkers and everything else, they pretty much changed dramatically at 2 years. That 2-year cut point really is the most important thing. Obviously, immune-related [adverse events] are often long term, and many people may unfortunately carry that burden for longer than that 2-year landmark. But for the most part, I would say that from an outcome perspective, I think most of us are pretty happy at 2 years. Even though it's still a relatively new regimen for people to consider, honestly, a lot of those patients were undergoing adjuvant immunotherapy anyway,” Meeks commented.

1. FDA approves durvalumab for muscle invasive bladder cancer. News release. US Food & Drug Administration. Published online and accessed March 28, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-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.

Firefighters face an increased risk of bladder cancer compared with those in the general population.

 However, the mechanisms by which some firefighters develop bladder cancer and others don’t is not fully understood.

, discussed the need to better understand the gene-environment interactions that contribute to bladder cancer development. That is, how genetic makeup informs individual responses to environmental toxins, such as those that firefighters encounter through occupational exposure. 

According to Porten, there is some evidence to suggest that some individuals may process these toxins more efficiently, thus lowering their risk of developing bladder cancer. Identifying who processes toxins efficiently, and more importantly, who does not, is an area of ongoing investigation.

“Once we can get a more clear understanding from that, then that might help us in understanding who's really at risk of developing these cancers,” says Porten.

Sima P. Porten, MD, MPH, discusses the need to better understand the gene-environment interactions that contribute to bladder cancer development.

Sima Porten, MD, on gene-environment interactions in bladder cancer development

Porten also cited a recent study led by investigators at UTHealth Houston that assessed the urinary proteomes of firefighters before and after responding to an emergency call. The study, which included 10 firefighters, showed differences in pre- and post-exposure samples.

Specifically, the authors reported, “Using a label-free quantitative proteomics platform, we identified and quantified 1325 unique protein groups, of which 45 proteins showed differential expressions in abundance in response to fire-smoke exposure (post) compared to the control (pre).”

Seven of these proteins were known to be associated with urological cancers.

According to Porten, studies like these will help to inform our understanding of gene-environment interactions in bladder cancer development.

1. Demers PA, DeMarini DM, Fent KW, et al. Carcinogenicity of occupational exposure as a firefighter. Lancet Oncol. 2022;23(8):985-986. doi:10.1016/S1470-2045(22)00390-4

2. Hwang J, Peng Z, Najar FZ, et al. Urine proteome profile of firefighters with exposure to emergency fire-induced smoke: A pilot study to identify potential carcinogenic effects. 

. 2024:927:172273. doi:10.1016/j.scitotenv.2024.172273

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

ImmunityBio has been awarded patents for the combination of BCG plus nogapendekin alfa inbakicept (Anktiva) in bladder cancer. In a recent interview with 

®, Suzanne B. Merrill, MD, FACS, was asked how she foresees the integration of this combination therapy, alongside the availability of recombinant BCG, influencing future treatment paradigms for non–muscle invasive bladder cancer.

Merrill said, “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. [In] our practice, I know myself and a lot of my colleagues have felt the need to reserve our critical supply of BCG to those who are BCG naive and just starting their journey with non–muscle invasive bladder cancer, rather than allocate this short-supply drug to our BCG-unresponsive patients. Again, that's where Anktiva is FDA approved now, so when we look at treating our BCG-unresponsive patients, thankfully, now we do have a couple of agents [that are] FDA approved that we can choose from, one of which is Anktiva.” Merrill is a urologic oncologist with Colorado Urology in Lone Tree.

Suzanne B. Merrill, MD, FACS, was asked how she foresees the integration of this combination therapy, alongside the availability of recombinant BCG, influencing future treatment paradigms for NMIBC

How rBCG EAP could open up access for Anktiva in bladder cancer

With the recent FDA-authorized expanded access program to provide recombinant BCG in the US, Merrill said this reasoning for not using Anktiva “is taken out.”

“Ultimately, I think it is going to at least allow us in our practice to now consider Anktiva alongside the other FDA-approved agents such as nadofaragene [firadenovec] [Adstiladrin], docetaxel and gemcitabine, and pembrolizumab [Keytruda], for example, on a more even playing field—as it should have been.”

“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.

The 40th Annual European Association of Urology Congress in Madrid, Spain, featured an extensive scientific program. In a recent video for 

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

The first study Wang highlighted was “Micro-ultrasound-guided versus MRI-guided biopsy for prostate cancer diagnosis: The OPTIMUM randomized clinical trial.”

“OPTIMUM was an international randomized study that compared micro-ultrasound guided vs MRI-guided biopsy for prostate cancer diagnosis,” explained Wang, a Society of Urologic Oncology fellow at Cleveland Clinic in Cleveland, Ohio.

“The authors noted that OPTIMUM demonstrated [that] micro ultrasound is non inferior to MRI fusion biopsy for detecting clinically significant prostate cancer and established itself as an appealing alternative to MRI for image guided biopsy. This would mean having a single procedure for both imaging and biopsy, and that could potentially be less expensive without using IV contrast, which is currently needed for multi-parametric MRIs,” Wang said.

The second study she highlighted was “Surgical outcomes and neoadjuvant safety with perioperative durvalumab for muscle-invasive bladder cancer (NIAGARA).”

 Previously reported data from the NIAGARA trial showed that perioperative durvalumab (Imfinzi) plus neoadjuvant chemotherapy extended event-free survival and overall survival vs neoadjuvant chemotherapy alone in muscle-invasive bladder cancer (MIBC).

 The FDA recently approved this treatment regimen for adult patients with MIBC.

At EAU, Wang said, investigators presented data on “the perioperative safety of durvalumab.”

“One of the main takeaways from this presentation was that durvalumab had no significant impact on the patient's ability to undergo surgery. In fact, if you look at the divide between the 2 arms, the addition of durvalumab actually increased the percentage of patients who underwent radical cystectomy from 83% (the chemo arm), compared to 88% (the chemo plus durvalumab arm). So if anything, it did not reduce the number of patients that could get their surgery in terms of cystectomy timing,” Wang said.

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

Betty Wang, MD, recaps 3 key urologic cancer studies from EAU 2025

The final study Wang discussed was “AURORAX-0087A: Urine Glycosaminoglycan Scores for Surveillance of Recurrence in Intermediate and High-risk Non-metastatic Clear Cell Renal Cell Carcinoma - An Observational Prospective Multicenter Diagnostic Test Cohort Study.”

“This study demonstrates that urine GAGome scores can be a promising biomarker for clear cell RCC [renal cell carcinoma] recurrence. It has a 97% negative predictive value, meaning a negative test can almost definitely rule out a recurrence. In terms of clinical impact, this could potentially reduce unnecessary imaging costs and radiation exposure to the patient,” Wang said.

1. Kinnaird A, Luger F, Cash H, et al. Micro-ultrasound-guided versus MRI-guided biopsy for prostate cancer diagnosis: The OPTIMUM randomized clinical trial. Presented at: 40th Annual European Association of Urology Congress. March 21-24, 2025. Madrid, Spain

2. Catto JWF, Al-Ahmadie H, van der Heijden MS, et al. Surgical outcomes and neoadjuvant safety with perioperative durvalumab for muscle-invasive bladder cancer (NIAGARA) Presented at: 40th Annual European Association of Urology Congress. March 21-24, 2025. Madrid, Spain

3. Powles T, Catto JWF, Galsky MD. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. 

. 2024;391:1773-1786. doi:10.1056/NEJMoa2408154

4. FDA approves durvalumab for muscle invasive bladder cancer. News release. US Food & Drug Administration. Published online and accessed March 28, 2025. 

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-muscle-invasive-bladder-cancer

5. Dabestani S. AURORAX-0087A: Urine Glycosaminoglycan Scores for Surveillance of Recurrence in Intermediate and High-risk Non-metastatic Clear Cell Renal Cell Carcinoma - An Observational Prospective Multicenter Diagnostic Test Cohort Study. Presented at: 40th Annual European Association of Urology Congress. March 21-24, 2025. Madrid, Spain

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

The FDA recently approved neoadjuvant durvalumab (Imfinzi) in combination with gemcitabine and cisplatin, followed by adjuvant durvalumab monotherapy following radical cystectomy, for adult patients with muscle invasive bladder cancer (MIBC).

Joshua J. Meeks, MD, PhD, an associate professor of urology at Northwestern University Feinberg School of Medicine in Chicago, Illinois and an investigator on the NIAGARA trial evaluating this treatment regimen, discussed the impact of the approval.

“The NIAGARA approval really begins to bring immunotherapy into the neoadjuvant setting. As providers who care for patients with muscle-invasive bladder cancer, we've become very familiar with giving chemotherapy to those who can get it; those who can't go to surgery. Either way, you do an operation, and then, based on the pathology, you make a decision about adjuvant immunotherapy. That’s the paradigm up until NIAGARA. NIAGARA changes that in a bunch of ways. First, if you look at the creatinine clearance for patients who are cis eligible—and everyone got GC as a backbone—they went down to 45, so that begins to increase the window of patients. I've heard medical oncologists concerned about giving chemotherapy to patients with a GFR of 59, so going down to 45 increases that pool of patients. That should be identified. In addition, there’s a statistically significant improvement in path response in patients who got durvalumab,” Meeks said.

Joshua J. Meeks, MD, PhD, discusses the impact of the approval of neoadjuvant durvalumab (Imfinzi) in combination with gemcitabine and cisplatin, followed by adjuvant durvalumab monotherapy following radical cystectomy, for adult patients with muscle-invasive bladder cancer 

Joshua J. Meeks, MD, PhD, discusses the impact of neoadjuvant durvalumab approval in MIBC 

Meeks added, “My sense is that it's something that going to start being offered to more patients, in general, because again, the people who are electing to do chemotherapy are usually wanting a full-court press, and this gives them another chance to intensify that and give a better chance to fight for survival.”

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

FDA recently approved perioperative durvalumab

 (Imfinzi) with neoadjuvant chemotherapy for adult patients with muscle-invasive bladder cancer (MIBC).

The approval was supported by data from the phase 3 NIAGARA trial (NCT03732677), which showed that perioperative durvalumab with neoadjuvant chemotherapy significantly extended event-free survival (EFS) and overall survival (OS) vs neoadjuvant chemotherapy alone.

, offered his thoughts on the significance of findings from NIAGARA and how the approval of perioperative durvalumab with gemcitabine/cisplatin will impact the multidisciplinary care of patients with MIBC. Galsky is the director of GU medical oncology at the Icahn School of Medicine at Mount Sinai and the associate director for translational research at the Tisch Cancer Institute in New York, New York.

Matthew D. Galsky, MD, offered his thoughts on the significance of findings from NIAGARA and how the approval of perioperative durvalumab with gemcitabine/cisplatin will impact the multidisciplinary care of patients with MIBC.

Matthew Galsky, MD, reacts to NIAGARA results, durvalumab approval for MIBC

Specifically, data from NIAGARA showed that at 24 months, the estimated EFS was 67.8% (95% CI, 63.6 to 71.7) in the durvalumab arm vs 59.8% (95% CI, 55.4 to 64.0) in the control arm (HR, 0.68; 95% CI, 0.56 to 0.82; 

 < .001). The median EFS was not reached in the durvalumab arm and was 46.1 months (95% CI: 32.2, NR) in the chemotherapy arm. At a median follow-up of 42.3 months, 35.1% of patients in the durvalumab arm and 46.4% of patients in the control arm experienced an EFS event.

"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. 

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