Benign Conditions

Benign Prostatic Hyperplasia

Bladder Cancer

Female Urology

Genitourinary Cancers

Genomic Testing

Hormone Therapy

Kidney Cancer

Challenging Anatomy

Innovative Techniques

Laser Lithotripsy

PCNL Tech & Devices

Ureteroscopy Tech & Devices

Kidney Stones

Men's Health

Next-Generation Imaging

Voiding Dysfunction

OAB and Incontinence

Pediatrics

Controveries in Urologic Cancer

Drug Therapy

Prostate Cancer

Sexual Dysfunction

UTUC

Cosmetic Surgery

Urologic Surgery

Business

Practice Management

Malpractice Consult

Health Law & Policy

Media

Case-Based Peer Perspectives

Investigator Perspectives 

Medical World News

Podcasts

Urology Medical Perspectives

UTv Videos

Peer Exchange

Special Report

Virtual Tumor Board

Insights

Medcast

Peers & Perspectives

Conferences

Conference Listing

Conference Previews 

Conference Recaps

Publications

Urology Times Journal

Editorial Advisory Board

Urologists in Cancer Care

Supplements and Featured Publications

Clinical Forums Recaps

CME/CE

Resources

Begin Your Journey: Tackling Burnout

Live Events

Interactive Tools

Job Board

Partners

Treatment Landscape Evolutions

Subscribe

Articles

“The differences in patient experience between UroLift System and Rezūm, particularly in terms of early recovery, sexual function, and overall satisfaction, are key considerations for both clinicians and patients selecting a treatment path," says Mark Rochester, MD, FRCS. 

UroLift may offer improved early recovery period vs Rezūm for BPH 

"The Inflation Reduction Act was a major step in the right direction. The question now is going to be, are commercial insurers going to follow Medicare and enact the same cap that they have as well," says Benjamin Pockros, MD, MBA.

Cutting drug costs for patients: key takeaways for urologists

"The combination demonstrated clinical activity and an acceptable safety profile in the perioperative setting for locally advanced, non-metastatic clear cell RCC," says Mehmet Asim Bilen, MD. 

Perioperative lenvatinib/pembrolizumab shows promise in non-metastatic ccRCC

The company plans to initiate the phase 2 monotherapy trial by mid-year. 

CD46-targeting ADC shows encouraging clinical activity in mCPRC

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

Urology Times is the leading resource for urologists & allied health professionals offering clinical analysis, policy perspectives, & practical advice.

About Us

Advertise

Editorial

Contact Us

Terms and Conditions

Privacy

Do not sell my Personnal Information

Urology Times | News & Insights for Urologists & Health Professionals

Facebook

LinkedIn

Spotlight

Peers and Perspectives

Clinical

1rem

Clinical Focus

 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

"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

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

FDA updates in urology: March 2025

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

Subcutaneous nivolumab under review in EU for solid tumors

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

FDA approves durvalumab/chemo for muscle–invasive bladder cancer

"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. 

RAG-01 elicits complete responses in NMIBC

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.

The estimated 24-month OS was 82.2% (95% CI, 78.7 to 85.2) in the durvalumab arm vs 75.2% (95% CI, 71.3 to 78.8) in the control arm (HR, 0.75; 95% CI, 0.59 to 0.93; 

 = .01). The median OS was not reached in either arm.

Adverse events were comparable between both arms.

Galsky noted, “The results of NIAGARA are important because this is the first improvement in neoadjuvant therapy since neoadjuvant therapy was initially shown to be beneficial for the treatment of muscle invasive bladder cancer.”

Videos

"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. 

Firefighters face an increased risk of bladder cancer compared with the general population. In 2022, the International Agency for Research on Cancer (IARC) classified firefighting as a class 1 carcinogen, which included “sufficient” evidence for a link in bladder cancer.

 While knowledge of occupational exposure does not necessarily influence treatment options, it can help explain why bladder cancer developed in the first place, 

®, Portendiscussed the firefighter-bladder cancer link, specifically touching on how word of mouth can help to inform and educate firefighters on risk factors and preventive strategies.

Porten is an associate professor of urology at the University of California, San Francisco.

Sima Porten, MD, discusses the firefighter-bladder cancer link, specifically touching on how word of mouth can help to inform and educate firefighters on risk factors and preventive strategies. 

Sima Porten, MD, discusses the need to educate on the firefighter-bladder cancer link

Porten began by acknowledging that there is a lack of awareness surrounding some of the signs of bladder cancer, including hematuria. Thus, knowing that firefighting is associated with bladder cancer may encourage discussions surrounding the need to get things such as hematuria evaluated.

Additionally, she explained how urologists and community members can play a role in advocating for preventive strategies for this population. Some ways to do this could be educating on the link between firefighting and bladder cancer, as well as ensuring that firefighters have adequate protective equipment.

She noted, “This is where the community can help each other in terms of making sure that we keep our firefighters safe and protected. 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.”


1. Demers PA, DeMarini DM, Fent KW, et al. Carcinogenicity of occupational exposure as a firefighter. 

. 2022;23(8):985-986. doi:10.1016/S1470-2045(22)00390-4

"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.

The FDA recently authorized an Expanded Access Program (EAP; NCT06800963) that will provide recombinant BCG (rBCG) to patients across the US. The program was initiated at U.S. Urology Partners, with 60 additional sites in the process of launching as well.

, of Urology of Indiana, an affiliate of U.S. Urology, discussed the potential impacts that this program may have in addressing the BCG shortage.

Eugene B. Cone, MD, of Urology of Indiana, an affiliate of U.S. Urology, discussed the potential impacts that the EAP may have in addressing the BCG shortage. 

Eugene Cone, MD, outlines potential impact of Expanded Access Program for rBCG

The program plans to enroll 100 participants with non–muscle invasive bladder cancer to assess clinical outcomes and safety with rBCG. If these both appear to be promising, Cone explained, ImmunityBio has the capacity for a larger scale launch on the market.

“It will have a very immediate impact if they do get approval to bring this to the market across the board, because it could potentially at least alleviate and potentially fix the BCG shortage, so patients would get access to BCG,” Cone said. “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.”

However, Cone noted some potential downstream effects as well. For example, he explained that if rBCG poses a cheaper option, newer therapies coming down the pike may face obstacles in getting access to the market or in reaching patients in the BCG-naïve setting.

“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.

For years, urologists and patients have dealt with the effects of the BCG shortage. A new expanded access program (EAP) authorized by the FDA, in which ImmunityBio is partnering with the Serum Institute of India to provide recombinant BCG (rBCG), seeks to alleviate the effects of the current shortage.

®, Suzanne B. Merrill, MD, FACS, discussed the impact of the BCG shortage.

“I think for all of us, across the world, the BCG shortage has greatly affected both practices and patients. Certainly, in our practice, we've had to undergo operational changes to ensure a better stewardship and correct allocation of this vital resource. It's definitely affected treatment decisions for our patients—whether or not to perform maintenance…Sometimes, patients have been shifted from using the standard of care BCG to potentially a chemotherapy agent, and so allowing the opportunity to investigate an alternative agent like recombinant BCG, I think, is a great opportunity to release the strain on our supply issues, and expand access, again, to what looks like a very comparable alternative to our standard of care Tice BCG. Again, it’s still yet to be fully vetted, but it looks very promising. I'm all for this great effort by ImmunityBio to provide us with an alternative option,” said Merrill, a urologic oncologist with Colorado Urology in Lone Tree.

Suzanne B. Merrill, MD, FACS, discussed the impact of the BCG shortage.

How recombinant BCG could ease strain of supply issues

When asked whether rBCG represents a paradigm shift, Merrill said time will tell.

“I think it's still yet to be determined if this is going to be a paradigm shift, as we just need more data. We need to understand a little bit better the safety and tolerability, which this EAP is going to address. We need a little bit better understanding if this genetically modified variation is going to prove to have maybe superior qualities, whether it's from an adverse event aspect, or potentially improved immunogenicity and better efficacy,” 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

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

An expanded access program (EAP) to provide recombinant BCG (rBCG) in the US was recently authorized by the FDA.

For the EAP, ImmunityBio has partnered with the Serum Institute of India, which develops rBCG, to provide an alternative source across the US. In an interview with 

®, Suzanne B. Merrill, MD, FACS, provided an overview of the EAP.

“One important aspect to get across…is that access to this EAP is pretty easy. What one would do is go to the ImmunityBio website. You could even just put in search terms [such as], “ImmunityBio,” “rBCG,” “recombinant BCG,” and you'll get to a place on their website where the practice can register: put in the provider's name, practice name, the reason for need for recombinant BCG, and then that will go to Anova, and Anova will review that and get back to you, usually within a quick turnaround time point. And ultimately, once Anova gets back to that practice, then they help to set up as this is a clinical trial reporting to the FDA safety data on the use of recombinant BCG in any patient that provider deems eligible for TICE BCG, but [for whom] they cannot or do not have access to the standard of care TICE BCG,” said Merrill, a urologic oncologist with Colorado Urology in Lone Tree.

Suzanne B. Merrill, MD, FACS, provided an overview of the EAP

Suzanne B. Merrill, MD, FACS, on EAP program for recombinant BCG

In the interview, Merrill also summarized rBCG.

“Recombinant BCG is a live but genetically modified BCG, which is derived from the Prague strain, and we use what is approved in the US, the Tice BCG strain. Now, Prague is reportedly a less virulent BCG strain and is associated with a better safety and tolerability profile due to a deletion of the phoP gene. It has 2 gene modifications that ultimately lead to what looks like an improved immunogenicity with CD8 and CD4 T cell stimulation, and also potentially an improved safety profile compared with earlier strains,” Merrill said.

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

In a recent long-term, multicenter analysis of patients undergoing robot-assisted radical cystectomy (RARC), the 12-year overall survival for the entire cohort was 49%, whereas the cancer-specific survival was 76%.

®, study author Neeraja Tillu, MD, said, “Given that many patients in this cohort have a history of long-term smoking, they frequently present with significant comorbid conditions, such as cardiovascular disease, pulmonary disorders, and other smoking-related illnesses. Consequently, the difference between overall survival and cancer-specific survival reflects a substantial impact of these non-bladder-related causes.”

Tillu, a urologic oncology fellow at Icahn School of Medicine at Mount Sinai in New York, New York, outlined the surveillance protocol recommended for patients defined as upstage: “regular…lab tests, urine cytology, and we do imaging every year to detect any distant or local recurrences at an early stage.

“For the non-upstage group, although oncological follow-up remains important, there is an emphasis placed on comprehensive health monitoring to address and manage non-cancer-related comorbidities proactively,” Tillu added.

Neeraja Tillu, MD, discusses study findings in a group of patients undergoing RARC for bladder cancer

What a long-term study of patients undergoing RARC reveals about upstaging

Tillu and her coauthors also found that a body mass index of at least 28 kg/m² reduced upstaging. When asked about this finding, Tillu said, “Our finding that higher BMI…is associated with reduced upstaging was an unexpected result, and this could reflect better nutritional status or metabolic differences, but confounding factors like selection bias, since it's a retrospective study, comorbid conditions and differential health care access should be considered. This does not directly influence our clinical management, although it does highlight the importance of comprehensive patient health optimization.”

Tillu said the take-home message of the study is, “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. Our study also revealed a notable incidence of pathological upstanding. Almost a third of our patients were upstaged, which highlights the limitations of current imaging modalities, and underscores the urgency for improved diagnostic techniques such as MRI with the PI-RADS system to accurately identify muscle-invasive disease at diagnosis. Practicing urologists should proactively discuss the option of upfront radical cystectomy in patients who exhibit high-risk features rather than relying solely on intravesical therapies to optimize oncological outcome.”

1. Tillu N, Ben-David R, Skokic V, et al. Long-term multicentre analysis of robot-assisted radical cystectomy for non-muscle-invasive bladder cancer. 

“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.

 The group also found “limited” evidence for a link in prostate, testicular, and colon cancers.

, outlines what is currently known about the link between firefighting and how it should influence screening practices. Porten is an associate professor of urology at the University of California, San Francisco.

Sima Porten, MD, discusses the link between firsfighting and bladder cancer.

Sima Porten, MD, on the increased risk of bladder cancer among firefighters

Specifically, Porten outlines the known hazards that increase the risk of bladder cancer among firefighters, including smoke inhalation, combustion byproducts, and chemicals from volatile organic compounds.

According to Porten, “There should be greater awareness that this is an occupation that now has actually been defined by a more larger governing agency as something to watch out for.” However, there is still limited knowledge on how this awareness should influence screening practices for patients with this occupational exposure. Porten acknowledged that this is an area of active investigation.

1. Demers PA, DeMarini DM, Fent KW, et al. Carcinogenicity of occupational exposure as a firefighter. 

"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. 

The bladder cancer space saw an explosion of advancements last year. In a recent interview with 

, of Michigan Institute of Urology, shared his thoughts on what is yet to come.

He noted, “[There’s] a lot going on in bladder cancer in the non–muscle invasive, muscle-invasive space, as well as in some of the biomarkers, which is exciting and will definitely have a huge impact on the management of your patients.”

Jason M. Hafron, MD, CMO, of Michigan Institute of Urology, shared his thoughts on what is yet to come in the bladder cancer space.

Jason Hafron, MD, predicts coming advancements in bladder cancer

In non–muscle invasive bladder cancer, Hafron touched on the recent approvals of nadofaragene firdenovec (Adstiladrin) in December 2022 as well as the approval of nogapendekin alfa inbakicept-pmln (Anktiva) in April 2024. He also highlighted several agents in the pipeline, including TAR-200, cretostimogene grenadenorepvec, and UGN-102.

In the muscle-invasive space, Hafron pointed to the recent readouts from several trials, including Alliance (NCT03244384), CheckMate-274 (NCT02632409), and NIAGARA (NCT03732677), which have had impacts on combinations in both in the adjuvant and neoadjuvant settings.

Lastly, Hafron focused on advancements with biomarkers in the space, namely ctDNA. According to Dr. Hafron, “ctDNA looks like, potentially, the PSA for bladder cancer, in that patients who undergo surgical resection that have positive ctDNA are more likely to respond to a checkpoint inhibitor and also the elevation of ctDNA often predates radiographic or imaging study changes.”

“[There’s] a lot going on in bladder cancer in the non–muscle invasive, muscle-invasive space, as well as in some of the biomarkers, which is exciting and will definitely have a huge impact on the management of your patients," says Jason M. Hafron, MD, CMO.  

Bladder Cancer

Latest News