Inlexzo Offers New Option for Patients With Unresponsive Bladder Cancer

On Sept. 5, 2025, the U.S. Food and Drug Administration (FDA) approved Inlexzo (gemcitabine intravesical system) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors.

This treatment delivers 225 mg of gemcitabine directly into the bladder through a catheter every three weeks for six months, then every 12 weeks for up to 18 months, and is considered a major advancement which offers a bladder-sparing option for patients who previously faced limited treatment alternatives.

Bill Parisi, a 74-year-old general contractor, recently sat down with us to share his experience with non-muscle invasive bladder cancer and participation in the SUNRiSE-1 clinical trial for Inlexzo. After facing the prospect of bladder removal, Bill’s involvement in the trial allowed him to preserve his bladder, maintain his daily work routine and achieve full remission, highlighting the impact of this newly approved therapy.

CURE: Can you share a bit about your journey with non-muscle invasive bladder cancer and how you first learned about the SUNRiSE-1 clinical trial?

Parisi: I noticed that blood was in my urine so I went to my general practitioner and she referred me to a urologist in the same town. He probed with the camera, and said, “OK, you have a tumor on your bladder. The first thing we're going to do is we're going to go in and take the tumor out…”

And then he said, "We're going to put it through a bladder wash for the next eight to 10 weeks." After those eight to 10 weeks, he came back and said, “Oh, that didn't help at all.” He said, “Well, now your options are to rebuild it or to remove the bladder.” And I said, "Well, I don't like those at all."

He knew a doctor, and he said, “It's possible he can get you in on a clinical trial, but there's no promises." From there, I went down to Dr. Daneshmand. He interviewed me and said, “OK, let's go in and take a look.”

He went in and took a look again with the camera, and he said, “Oh, you have a spot there.” That's what the doctor was concerned about after they had removed the tumor. From there, he said, “OK, the first thing I have to do is have to take the spot out before we start the trial.”

And then we started the trial.

How did participating in the trial for Inlexzo influence your treatment experience compared with previous therapies you may have received? What changes have you noticed in your overall health?

This option, of course, presented the possibility that I wouldn't have to remove my bladder. That was a very important situation as far as my options were concerned. And, oh, my goodness, the fact that I still have my bladder. The fact that I'm not carrying a bag around in general.

Of course, I monitor my health much closer, and so did the clinical trial. There were a lot of things like, for instance, I've been diabetic for 25 years, and I was always monitoring that very closely, because I've been on the same drug for almost 25 years now, because I do keep close tabs on it.

And of course, not having a bag on me made the world of difference. Unfortunately, my wife passed away almost three years ago.

I'm so sorry. That must have been a really difficult time for you.

I'm 74 years old, I’m not dead yet. So, that makes a big difference as far as my love life, you know, which would have been very hard if I had a bag.

That respect alone, God, I'm like the richest guy in the world; I'm a winner.

You mentioned you're a general contractor. Can you tell me a little bit about how your day-to-day life has changed, if at all?

OK, so that's a great question. Because all through the trial (I only retired a year ago), I was still working every day.
As a matter of fact, I tried to get Dr. Daneshmand to schedule me first thing in the morning so I could go back to work in the afternoon, and many days, I did. So, like I said, the whole time I was through the trial, I was still working.

Again, think of trying to work, climbing onto things, climbing into the attics, or just in general working. Carrying a bag would have been horrendous! It would have really curtailed my business life.

I mean, I could have retired at 65, but I just enjoyed working and the people that I dealt with. So, that made a big difference.

Well, I'm glad that the trial was able to help you with that.

Help me? This trial didn’t help me. It saved my life, in many ways.

That's wonderful. So, you're fully in remission now is my understanding.

Yeah.

That's fantastic. So, what advice would you give to patients who are considering enrolling in a clinical trial?

Fight. Fight. Follow that prescription. Whatever they say for you to do, follow that prescription. That is the main important thing in order to be successful. A lot of times, I heard that there were a couple of people that didn't stick with the trial, which is beyond me or why somebody would decide not to stick with the trial.

There’s no doubt that it's a discomfort to get down to the hospital, you're sitting waiting, then to go through the procedures. It's not the most comfortable thing. But once you get past it, the difference of having bladder cancer and losing your bladder, it's inconceivable that somebody would not stick with it.You see what I'm saying?

And thanks to people like you, we were able to get this approved so even more people can take advantage of it.

When I first met Dr. Daneshmand, she asked me, “Why did you decide to do this? Why go through the inconvenience?”

I said, "Listen, if one of my grandchildren would need this treatment or somebody I know, or somebody I don't know, if this works, and it's passed [through FDA approval], like it did…” I think of any person now that is going to have the procedure and go through the trial.

Here you are in the time of your life that you're going to want to go on trips. You're going to start really enjoying life and not working hard, and you're going to fight this now.

With the drug and the way it's put in, I didn't find it as uncomfortable as a lot of other people. People say to me, people that had the procedure, they say, “How did you do it?” And I just said, “Look at the alternative.” This is the part that is fantastic. I've done way harder things in life. So, you know, it's just that way.

Transcript has been edited for clarity and conciseness.

Reference

1. FDA Approves Inlexzo for Some With Non–Muscle Invasive Bladder Cancer, by Alex Biese. CURE; Sept. 9, 2025. https://www.curetoday.com/view/fda-approves-inlexzo-for-some-with-non-muscle-invasive-bladder-cancer

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