Transforming Bladder Cancer Care: A Conversation with Dr. Mark Schoenberg

October 10, 2025

Transcript

Voice over:

This is Bladder Cancer Matters, the podcast for bladder cancer patients, caregivers, advocates, and medical and research professionals. It’s brought to you by the Bladder Cancer Advocacy Network, otherwise known as BCAN. BCAN works to increase public awareness about bladder cancer, advances bladder cancer research, and provides educational and support services for bladder cancer patients and their loved ones. To learn more, please visit BCAN.org.

Rick Bangs:

Hi, I’m Rick Bangs, the host of Bladder Cancer Matters, a podcast for, by and about the bladder cancer community. I’m also a survivor of muscle invasive bladder cancer, the proud owner of a 2006 model year neobladder and a patient advocate supporting cancer research at the Bladder Cancer Advocacy Network, or as many call it, BCAN, producers of this podcast.

Today we’re featuring UroGen as September 2025’s partner in progress. UroGen’s mission is treatments designed to transform the paradigm in uro-oncology. While we’ll be talking about UroGen therapies including Zusduri, it’s important to remember that different treatments have different result in patients and your results may vary.

I’m pleased to welcome today’s guest, Dr. Mark Schoenberg. Dr. Schoenberg is a urologist practicing in Bronx, New York. He studied at the University of Leningrad and received his undergraduate degree in Russian and Eastern European Area studies from Yale. Dr. Schoenberg joined the faculty of the James Buchanan Brady Urological Institute at Johns Hopkins in 1994, focusing his practice and research efforts on the diagnosis and treatment of patients with bladder cancer.

Speaker 3:

Zusduri mitomycin for intravesical solution is a prescription medicine used to treat adults with the type of cancer of the lining of the bladder called low grade intermediate risk, non-muscle invasive bladder cancer, LGIR-NMIBC. After you have previously received bladder surgery to remove tumor and it did not work or is no longer working, you should not receive Zusduri if you have a hole or tear perforation of your bladder or if you have had an allergic reaction to mitomycin or to any of the ingredients in Zusduri.

The Zusduri clinical trials study 223 patients with recurrent LGIR-NMIBC. They received Zusduri once a week for six weeks. 78% of patients had no detectable tumor at three months after treatment with Zusduri. 79% of patients who had no detectable tumor at three months were still tumor free 12 months later.

The most common side effects of Zusduri include increased blood creatinine levels, increased blood potassium levels, trouble with urination, decreased red blood cell counts, increase in certain blood liver tests, increase or decreased white blood cell counts, urinary tract infection, and blood in your urine. Stay tuned for the full important safety information that will be presented later in this podcast.

Rick Bangs:

He founded the Bladder Cancer Think Tank in 2006 and is also a founding member of the Bladder Cancer Advocacy Network. In 2014, Dr. Schoenberg was named Professor and University Chair of Urology at the Albert Einstein College of Medicine. Over the next decade, he led the expansion of the department’s nationally ranked clinical and academic programs, which also includes a departmental rock and roll band, Clean Catch and Company.

Since 2017, Dr. Schoenberg has also served as the Chief Medical Officer of UroGen Pharma Incorporated. In his free time, he likes to read cook, ski and spend time with his wife and their two daughters. Dr. Schoenberg, welcome.

Dr. Mark Schoenberg:

Rick, thank you so much for having me today. It’s a pleasure to be here.

Rick Bangs:

Pleasure to have you as well. So you have a very long history of being extremely patient-centric and you actually wrote a book for patients about bladder cancer way back in 2000. So, what was your catalyst for writing that book?

Dr. Mark Schoenberg:

So, I was lucky early in my career to have an opportunity to focus on caring for patients with bladder cancer at a time when bladder cancer was really not receiving the type of attention that it does today. And what I found in my day-to-day life as a clinician was that I was telling people the same story over and over again, talking to them about the importance of staging and grading, the importance of comprehensive evaluation.

And a very significant segment of my time with patients was spent talking to them about different options for treatment, some of which they were very unfamiliar with at the time, bladder sparing, for example, in patients with muscle-invasive cancer. So, I eventually concluded that what I really needed to do was write down what I kept telling people every day in my office practice so that the information could be more widely disseminated.

Because in my conversations with my peers, I realized all of us were kind of saying the same things to patients over and over again, but patients didn’t have a reference to go to reinforce those conversations.

Rick Bangs:

Excellent. So, I think it’d be an understatement to describe you as BCAN’s very first partner in progress because you were catalytic to BCAN’s founding in 2005, and you organized the very first bladder cancer think tank in 2006. What needs did you believe the bladder cancer community had at the time, John Qualley, who was your patient and eventually and his wife, Diane, walked into your clinic back in that same year that you published this book?

Dr. Mark Schoenberg:

So, I had a funny experience talking to a colleague who was focusing at the time on prostate cancer care. And I was lamenting the fact that there seemed to be very little funding or interest in focusing attention on the plight of bladder cancer patients or the lack of information we had associated with the science and the clinical care of bladder cancer patients.

And this friend who was genuinely a friend, turned to me in the midst of the conversation and said to me, this was three decades ago, and said, “Nobody cares about bladder cancer. Mark.” Sadly, he was joking, of course, but the truest things, as Shakespeare said, are said in jest. And at the time, it was really true, everybody was very concerned about patients with prostate cancer and breast cancer and bladder cancer was really kind of an orphan.

And a variety of things have come to pass that have really focused our attention on bladder cancer in ways that I think none of us could have predicted, not the least of which is the discovery of checkpoint inhibition pharmacology, and the importance of those drugs by Jim Allison and colleagues at a variety of institutions, including MD Anderson.

But at the time, the goal of the think tank, which sort of arose spontaneously and coincidentally about the time that John Qualley and Diane were thinking about an organization for bladder cancer patients, was to try to give people a place to go to get information. And I think one of the nice unanticipated benefits of the way BCAN and the think tank grew together was a desire to incorporate or hear the voices of many different stakeholders within what we now understand to be the bladder cancer community. Not just patients and their advocates, but physicians and scientists and also partners in the world of pharma who are very committed, obviously, to bringing new tools and drugs for the treatment of this disease. So at the time, the idea was to create a destination where there was none existing.

Rick Bangs:

And so what aspirations might you have had for this thing that ultimately became BCAN?

Dr. Mark Schoenberg:

Well, I was hoping that we would, and listen, credit to Diane and John and all of the people who, and this is a tremendous group effort, so credit to John and Diane for leading this, but you know only too well, Rick, but it takes many hands to make this work light. And there were many hands involved.

I think our aspiration was that we would create a community that would focus attention nationally on the plight of bladder cancer patients, on the things that mattered to the bladder cancer community, and not just patients, but their family members, and create a discussion that involved not only things related or aspects of the conversation, not only related to how we care for patients, but how we do discovery. What are things that are meaningful, what are topics that are not being addressed, and at the time, nothing was being addressed in a coordinated manner.

So, it was a wonderful time to be doing this because the field was open. Survivorship hadn’t been really pioneered. We hadn’t thought about how advocates could influence how pharma thinks about what’s really meaningful. We hadn’t even gotten new things that have been pioneered by researchers who are very involved with BCANs, like Sarah Psutka, Angie Smith and colleagues at UNC, people who are now actively talking about de-intensification of care for patients with low-grade disease.

So, there were lots of opportunities to have conversations about many different aspects of the care and study and execution of care for this disease with many voices contributing. And I think that’s what we were all hoping would happen and what BCAN was supposed to be about. And lo and behold, that is what BCAN is about, which is really a wonderful success. And again, a huge credit to Diane and John and all of the people who work with them to make it a reality.

Rick Bangs:

Right. And they’ve really created this network, this multidisciplinary perspective, which is so wonderful. So, why did you join UroGen?

Dr. Mark Schoenberg:

So, I was minding my own business and I got a call from a colleague who is a very prominent urologic oncologist, a guy named Arie Belldegrun, who has been, in addition to being a serious immunologist and cancer surgeon at UCLA for many years, a serial entrepreneur in the world of pharma. And he called me up and he said, “Hey, there’s a little company in Israel that’s working on a technology that’s going to be very important to taking care of patients with bladder cancer and you need to be involved.”

And my response to that was, “What are you talking about?” I got another call from Arie and he said, “Okay, stop complaining and go meet the guy who’s running the company,” who was a young Israeli CEO. And I flew to Milan to meet him at the European Urologic meeting that year, which was back in 2013. And this very compelling young man convinced me that this wasn’t a dumb idea as I had thought that there really was a destination for this technology. It was just going to take hard work and could I help him do it?

And I said, “Maybe I’ve been pigheaded about this whole thing.” So, that’s how I got involved. But I got involved despite my own recalcitrant and probably wrong-headed ideas about the technology [inaudible 00:11:26]. And thankfully I was able to say I was wrong, and it changed my mind because it has turned out to be a really educational, exciting experience to be involved not only with the company, but with the creation of now a number of medicines that I think are changing the way we think about caring for patients with urothelial cancer.

Rick Bangs:

So, you decided to join and you are the Chief Medical Officer. So, what does somebody in a Chief Medical Officer role do?

Dr. Mark Schoenberg:

Yes. Well, remember this is a small startup company. And when I tell you that this company started in a shack suburb of Tel Aviv, I’m not kidding. The company chemist who is now head of the R&D program in Israel, where the R&D team still sits, even though the majority of the company is located in the United States, the head of the chemistry department, who was an organic chemist from the Weizmann Institute, had created a laboratory for herself in one of the bathrooms of the office.

So when I say startup, I’m not kidding. I mean, this was really bare bones. And thankfully, we’ve moved to a new office in Tel Aviv that looks nicer than that, and she has a real lab now. But in any event, my role then, and quite honestly, my role now, is to be the in-house doctor. There aren’t that many urologists in the company.

There are a couple of people who know urology well, and I’ve been the sounding board for a variety of things, up to and including how we do clinical trials, what’s the right way to approach patients and think about the disease process we’re interested in. So, I’m still acting as a doctor, which is kind of nice for me, the value I can bring to the company.

Anybody who’s worked in pharma, anybody who’s seen how drugs really get into your medicine cabinet, understands that you need a tremendous number of talents at the table in order to comply with all of the regulations and requirements to make a drug safe and effective and convince the food and drug administration that you’ve done those things. So, I have tremendous respect for all of the colleagues involved in developing these medicines and bring them to market. But again, my role is to be the urologist on the team, and that’s still my role.

Rick Bangs:

And tell me what UroGen’s mission or vision is and how it translates to patient care

Dr. Mark Schoenberg:

From the get-go, and this is the apocrypha of corporate storytelling. The origin story of the company is an organic chemist runs into a urologist at a cocktail party in Tel Aviv in 2004, and the urologist says, “Hey, we put medicines in the bladder, but they get washed out right away because people pee a lot.” And the organic chemist says, “We got something for that.”

And it turns out what that something was is the core technology that is the foundational approach that UroGen is taking to delivering medicines locally, the urinary tract, which is what’s called a reverse thermal gel. This is a mixture of polymers that when chilled is a liquid, it does exactly the opposite of what you’d expect water to do.

When you chill water, it turns into ice. When you warm it up, it turns into a liquid, and then if you warm it up enough, it turns into steam. Well, this mixture of polymers, if you cool, it turns into a liquid, and when you warm it up, the body temperature, it turns into a gel, and the gel can be mixed with a variety of drugs.

The drug that’s currently being used in the marketed products from UroGen, it’s called Mitomycin, the drug that urologists have been using for 50 years to treat the urothelial cancer in water. Mixing it with the gel, permits you to put it in the inside of the bladder where it remains and treats the tumor. From that, you go to the possibility of what UroGen’s products really do, which is locally dissolve or ablate cancers without the need for surgery.

Because remember, everybody who has historically had urothelial cancer taken out of the bladder if it’s non-invasive, for example, always gets an operation called a transurethral section of the bladder tumor before getting any additional therapy on the bladder. These technologies make it possible for you to go to the office, have your doctor put the medicine, for example, in your bladder, and we can talk about the results from the most recently published papers about this approach in patients with particularly chronically recurring low-grade disease, what’s referred to amongst professionals as intermediate risk, non-invasive bladder cancer.

So, that long shaggy dog answer to your question ends in what could be more patient-centric than giving patients an opportunity to choose between another operation, which has been the historical standard of care for people who have recurrent disease, and an in-office, non-surgical nursing-administered medication.

Rick Bangs:

Right. And not everybody can have surgery.

Dr. Mark Schoenberg:

So again, to answer your question directly, the goal of UroGen is to provide people with non-operative effective therapies for urothelial cancer, which has heretofore been treated by recurrent and repetitive intervention at a surgical level.

Rick Bangs:

So, all right, so let’s talk about what are the segments you’re playing in and what are these agents, and if there’s anything you want to mention about clinical trials going on now, that would be fine.

Dr. Mark Schoenberg:

Sure. So, the indication for the drug that was just approved on June 12th by the FDA, the drug’s name is Zusduri, and investigators who participated in the studies to get this approved know it as UGN 102, but the trade name is Zusduri. And this drug was approved for the treatment of low-grade intermediate risk, non-muscle invasive bladder cancer that is recurrent.

Ashish Kamadat at MD Anderson has done a lot of work with the International Bladder Cancer Consortium to help us understand different risk groups in the pantheon of disease that we call non-invasive bladder cancer. Low-risk patients have a solitary small tumor. High-risk patients have high-grade tumors associated often with carcinoma in situ, frequently invading the lamina propria, grade three tumors. These are the kinds of things that are high risk.

And then there’s this sort of wastebasket of intermediate risk. And what is intermediate risk? Well, it’s a solitary low-grade tumor greater than three centimeters, multifocal recurrence within less than a year. There are a variety of characteristics.

Well, it turns out that this middle group is a very big group of patients in the United States. The estimate is that somewhere between 60 and 80,000 people a year conservatively have this disease. Whatever the number is, many thousands of Americans are constantly going through repetitive surgery to manage low-grade recurrence of disease.

Quite honestly, it’s important to remember based on SEER data that patients have multiple recurrences. People with this disease, 67% have two or more recurrences during life, a quarter or almost a quarter, have more than five recurrences. So, these are people who are constantly cycling through urologist offices and their operating rooms operations over and over again.

So, the indication as stated by the FDA and in the label, is for the treatment of this group of people. So, this really is an opportunity for patients to think creatively with their doctors about something other than another operation, if and when they recur. And of course, unfortunately, many patients with non-invasive bladder cancer do recur. That’s the cycle of disease, unfortunately, it’s a chronic illness.

Rick Bangs:

Right, right. So why does UroGen focus on cancer, urology, bladder cancer? What’s behind that?

Dr. Mark Schoenberg:

Well, I think, again, thinking back to the creation story I told you earlier, this is really a company that was founded based on a question posed by urologists to a group of scientists. So no, that actually is true, all joking aside. And so the origin of the company is focused on treating urologic disease.

Now, I think what the question you, you’re implicitly asking is where else could this technology go? And that is something that is actively discussed within the company, and there are many possible avenues for thinking about where a reverse thermal gel that can carry many different types of molecules, some of which we’re already investigating internally, could go to treat other diseases.

But right now, we’re focused on obviously the two diseases that our approved products treat, as well as developing other medicines to treat, for example, high-grade disease. We have an interest in treating high-grade disease, as do many others in the field. We’d like to bring other types of medicines to the treatment of high grade disease. And we know that the gel technology can carry both very small and very large molecules of very different types, large proteins, small molecules.

So, there’s a lot of flexibility in terms of the type of payload we can deliver to the service of the bladder or potentially to other warm, wet services in the body. Spend a lot of time internally talking about those opportunities, and who knows? As funding increases, as the fortunes of the company improve, we hope to have the funding to be able to explore those additional targets as well.

Rick Bangs:

We’ll look forward to hearing some results on those studies. So can you tell me what kind of work have you and UroGen done with BCAN in the past and what’s next for your partnership?

Dr. Mark Schoenberg:

So, what we have done historically is we’ve been very supportive of the think tank, of the walks. And we are incredibly grateful to BCAN because BCAN has been very supportive of UroGen’s efforts as well. I don’t think I need to tell you this, but BCAN came and spoke at the open session for the FDA approval or advisory committee meeting for Zusduri.

So, we are working hand in hand with BCAN for the very specific purpose of providing patients with the opportunity to avail themselves of alternative treatment options once they’re approved to be safe and effective. And it’s been a great partnership.

Rick Bangs:

Excellent, excellent. Now, what do you see in the future for bladder cancer therapy?

Dr. Mark Schoenberg:

I think that there is a lot of excitement in this field, and you only need to look across pharma to know that there are huge companies now really dedicating a lot of resources, J&J, CG Oncology, just to name a few, and lots of startups bringing novel, interesting therapies to bear on this disease. So, it is very refreshing for me and very enlivening to see that, in contrast to what my friend said three decades ago, nobody cares about bladder cancer, now it seems everybody cares about bladder cancer.

It’s really, really fascinating to see. And it’s great because we know how many patients in America alone are affected by bladder cancer, have to deal with its chronic manifestations and all the challenges. So, I think you’re going to see lots of new drugs and lots of new types of approaches, combinations, and even some interesting… I know there are people working on oral medications for local disease as well.

So, I think we are just entering this renaissance of innovation and it’s going to be a very exciting time for physicians caring for patients who have bladder cancer. And luckily, that will provide relief for people who have heretofore not had as many options as they deserve.

Rick Bangs:

None of which could have been predicted when you wrote your first book. So, this is just excellent.

Dr. Mark Schoenberg:

Certainly not. Certainly not. Yes. The book would need a lot of new chapters.

Rick Bangs:

Yes, that’s right.

Dr. Mark Schoenberg:

For sure. That’s for someone else to write.

Rick Bangs:

Yes, yes. It’s a good problem to have, but somebody else will take it on. Any final thoughts?

Dr. Mark Schoenberg:

No, listen, it’s been wonderful to talk to you. Thank you so much for permitting me to come on the podcast. It is a real pleasure to talk to you and to work with BCAN and we look forward to continued wonderful partnership and to making more progress to improve the lives of bladder cancer patients.

Rick Bangs:

Yeah, it’s been an honor for me as well. So Dr. Schoenberg, I want to thank you for sharing UroGen’s bladder cancer story and for your part in making BCAN what it has become and in creating better todays and more tomorrows for bladder cancer patients and families. If you’d more information on bladder cancer, please visit the BCAN website, www.bcan.org.

In case people would like to get in touch with Dr. Schoenberg, they can reach out to communications at BCAN.org. Just a reminder, if you’d like more information about bladder cancer, you can contact the Bladder Cancer Advocacy Network at 1-888-901-2226.

That’s all the time we have today. Be sure to like, comment and subscribe to this podcast so we have your feedback. Thank you for listening and we’ll be back soon with another interesting episode of Bladder Cancer Matters. Thanks again, Dr. Schoenberg.

Dr. Mark Schoenberg:

Thank you.

Speaker 3:

Please see the link to the full prescribing information on the podcast webpage or available at www.zusduri.com. Zusduri, important safety information, contraindications. Zusduri is contraindicated in patients with perforation of the bladder or in patients with prior hypersensitivity reactions to mitomycin or any component of the product. Warnings and precautions, risks in patients with perforated bladder. Zusduri may lead to systemic exposure to mitomycin and severe adverse reactions if administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised. Evaluate the bladder before the intravesical instillation of Zusduri and do not administer to patients with a perforated bladder or mucosal compromise until bladder integrity has been restored.

Embryo-fetal toxicity based on findings in animals and mechanism of action, Zusduri can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of mitomycin resulted teratogenicity. Advise females of reproductive potential to use effective contraception during treatment with Zusduri and for six months following the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Zusduri, and for three months following the last dose.

Adverse reactions, common adverse reactions, the most common, greater than or equal to 10% adverse reactions including laboratory abnormalities that occurred in patients treated with Zusduri were increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils and hematuria.

Additional adverse reactions information, clinically relevant adverse reactions occurring in less than 10% of patients who receive Zusduri included increased urinary frequency, fatigue, urinary incontinence, urinary retention, urethrostenosis, genital pain, urinary urgency, genital edema, genital pruritus, genital rash, urethritis, acute kidney injury, balanopasthesis and nocturia.

Use in specific populations, lactation. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with Zusduri for one week following the last dose.

Preparation and administration information, Zusduri is to be administered by intravesical instillation only. Do not administer Zusduri by pylocalacil instillation or by any other route. Zusduri must be prepared and administered by a healthcare provider. To ensure proper dosing, it is important to follow the preparation instructions found in the Zusduri instructions for pharmacy and administration instructions found in the Zusduri instructions for administration.

Zusduri may discolor urine to a violet to blue color following the instillation procedure. Advise patients for at least 24 hours post-instillation to avoid urine contact with the skin, to avoid urine sitting on a toilet and to flush the toilet several times after. Use advise patients to wash hands, perineum or glands with soap and water after each instillation procedure.

Zusduri is a hazardous drug follow. Applicable special handling and disposal procedures. Please see accompanying full prescribing information, instructions for pharmacy and instructions for administration.

Zusduri is a trademark and UroGen is a registered trademark of UroGen Pharma Limited. Copyright 2025 UroGen Pharma Inc. All rights reserved.

Voice over:

Thank you for listening to Bladder Cancer Matters. A podcast by the Bladder Cancer Advocacy Network or BCAN. BCAN works to increase public awareness about bladder cancer, advanced bladder cancer research, and provide educational and support services for bladder cancer patients. For more information about this podcast and additional information about bladder cancer, please visit BCAN.org.