After Immunotherapy Failed, a Bladder Cancer Patient, 81, Joined a Clinical Trial and the ‘Pretzel’ Treatment Spared His Bladder — Offering New Hope for Others

His first line of defense was Bacillus Calmette-Guérin, or BCG, an immunotherapy that has anchored bladder cancer care for decades. Placed directly into the bladder, BCG rallies the immune system to attack cancer cells, and for many patients it works. But not for everyone.

When the cancer persists or returns despite treatment, doctors describe it as “BCG-unresponsive,” and the standard recommendation has long been a radical cystectomy, the surgical removal of the bladder.

That’s a daunting prospect. A cystectomy is a major operation that permanently changes how the body passes urine, and many patients understandably hope to find another way. Dr. Amy Luckenbaugh, a urologic oncologist at Vanderbilt Health, told Vanderbilt Health News that removing the bladder for a non-invasive cancer is, for many people, “a hard sell.” That’s why the growing number of bladder-sparing options represents such meaningful progress.

Inlexzo: A New Option For Bladder Cancer Patients When BCG Immunotherapy Stops Working

Access to BCG itself has also been a challenge. The drug has been in short supply for years, with only one manufacturer supplying the U.S. market. A 2023 white paper from the End Drug Shortages Alliance estimated that the market was producing only about 69% of the BCG needed in the U.S., and that thousands of patients a year may not be able to receive optimal treatment.

Merck, the drug’s maker, said in 2025 that it expected a new manufacturing plant to open by late 2026, pending regulatory approval, which would triple its BCG production capacity, according to the Bladder Cancer Advocacy Network. In the meantime, many doctors have turned to alternatives such as the chemotherapy combination gemcitabine and docetaxel.

Delahoussaye, a former smoker who quit decades ago and who suspects he was exposed to harmful chemicals during his working years, had spent a full year on BCG without clearing the cancer, according to Vanderbilt Health News.

That left him weighing a clinical trial against bladder removal, a lengthy operation that usually means several days in the hospital and, for about one in three patients, a return trip within a month, the outlet noted.

He ultimately chose the trial. In October 2024, after three surgeries and a year of BCG that hadn’t worked, he became the first Vanderbilt Health patient in SunRISe-5, a phase 3 study of a gemcitabine-releasing device called TAR-200, the outlet reported.

Rather than exposing the whole body to chemotherapy, the device releases the drug slowly and directly onto the bladder lining.

TAR-200 was later approved by the FDA under the name Inlexzo for patients whose BCG-unresponsive cancer includes carcinoma in situ, a flat, high-grade form of the disease. SunRISe-5 is testing whether it can also help patients with papillary tumors, which grow in finger-like projections from the bladder lining.

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Looking back on his journey, Delahoussaye told Vanderbilt Health News that the cancer in his bladder had once looked “like a coral reef.” The early months of the trial were tough, he admitted, since the device releases chemotherapy into the bladder around the clock.

“It’s not easy,” he said, “but I wanted to do it not only to cure my cancer but also to help people after me.”

His wife, Roxane, said she’s always tried to stay optimistic, even though her husband has faced serious health challenges before, including Merkel cell carcinoma, a rare skin cancer, in 2012. She admitted she was worried when bladder cancer came along, but knowing it hadn’t spread beyond the bladder gave her comfort.

“That helped me sleep at night,” she said. “It was good news.”

She also credited research nurse Bree Duncan with keeping him going when he wanted to quit. According to Roxane, Duncan would encourage him to stay with the trial and remind him how well he was doing.

That persistence paid off. Today, no cancer shows up in his urine or blood, and the bladder he once expected to lose is healthy again.

“The inside of my bladder looks like it did the day I was born,” he said.

How The Device That Helped Delahoussaye Works

In September 2025, the U.S. Food and Drug Administration approved Inlexzo (also known as the gemcitabine intravesical system or TAR-200) for adults with BCG-unresponsive NMIBC. Previously, these patients were left with extremely difficult treatment decisions.

The approval, granted under Priority Review and supported by a Breakthrough Therapy Designation, is a much-needed milestone. It’s the first intravesical drug-releasing device, or device that releases medicine directly into the bladder, ever approved for bladder cancer.

The treatment involves several steps:

• A device smaller than a quarter, shaped like a pretzel, is placed inside the bladder.
• It slowly releases chemotherapy directly into the tumor environment, continuously, over three weeks.
• It is then removed and replaced at the next visit.

The whole procedure can be done during an office visit.

“What makes Inlexzo distinct is that it’s not simply delivering intravesical gemcitabine in the way we would traditionally think about it,” Dr. David Aggen, a genitourinary medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, told SurvivorNet in an earlier interview.

“It’s an intravesical delivery system where a device is inserted into the bladder, it remains in place for about three weeks, and then it provides a sustained local release of gemcitabine, which is very different from standard intravesical gemcitabine, where the drug is instilled as a liquid and may have a short dwell time.”

Dr. Aggen adds, “The value of TAR-200 is that it delivers gemcitabine slowly over the course of weeks.”

Gemcitabine, the chemotherapy agent inside the device, has been used in bladder cancer for years. But its effect when administered conventionally has always been limited by the fact that it only stays in contact with bladder tissue for a short window (sometimes 30 minutes to an hour) before being excreted in urine. Inlexzo sidesteps that problem.

“We think the sustained exposure of gemcitabine may result in more drug exposure ultimately to the cancer and that you may have better outcomes. That’s the particular advantage,” Dr. Aggen adds.

In clinical trials, about 8 out of 10 patients had no detectable cancer at some point during treatment, suggesting a strong level of activity in this difficult-to-treat population.

An “intravesical device,” may sound intimidating, but Dr. Aggen notes that the insertion and removal is a relatively simple in-office procedure.

“The device is inserted as a linear device,” he says. “Inside the bladder, the device is about the size of a quarter. It folds up almost in a pretzel-like shape, and then it’s retrieved at every three-week installation to introduce a new device.”

Patients don’t need to hold their urine or follow any special preparation before the procedure beyond arriving with a non-empty bladder. After insertion, they’re advised to stay well-hydrated (about six to seven cups of fluid per day) and to urinate normally. There’s no need to restrict activity or alter daily routines.

Delahoussaye told Vanderbilt Health News he drinks up to 96 ounces of water a day, about 12 cups, to help keep the device from lodging in his bladder, which can cause irritation. Hydration needs can vary from patient to patient, so follow your care team’s specific guidance.

The dosing schedule runs over two years in two phases:

• In the first six months, patients receive the device every three weeks (eight total doses).
• After that, dosing shifts to once every 12 weeks for up to 18 more months (six additional doses).

Despite the enthusiasm around Inlexzo’s efficacy, Dr. Aggen emphasizes that this treatment is not for everyone with BCG-unresponsive disease, and thoughtful patient selection is essential.

“Inlexzo is a favorable option for patients who have BCG-unresponsive disease,” he says. “I think that patients need to have a component of carcinoma in situ. Patients that have pure T1 disease that’s refractory to BCG [still progresses on BCG] are a much higher risk group, and perhaps those are patients who should be sent to their urologist for a discussion of an early cystectomy.”

The treatment schedule can also be taxing on patients, he adds.

“It does require device installation every three weeks for a set period of time, and you need a patient who’s willing and agreeable to go through those procedures,” Dr. Aggen adds. “It’s very distinct from BCG, which is given weekly for six weeks, and the frequency of administration may be cumbersome for certain patients.”

His advice to patients is to work closely with their urologists and care teams.

“With any intravesical therapy, it’s really important to be on the same page with your urologist about what the surveillance plan is so you don’t miss a cancer coming back more aggressively,” he adds.

Overall, Inlexzo represents a promising new kind of treatment, one that delivers chemotherapy directly to the bladder over time and may help some patients avoid or delay major surgery, but it is not the right choice for everyone.

What This Means for Other Patients

Delahoussaye’s path ran through a clinical trial, but patients whose cancer stops responding to BCG now have several FDA-approved options to discuss with their doctors.

In addition to Inlexzo, these include Keytruda (pembrolizumab), an immunotherapy given by IV that became the first novel drug approved for BCG-unresponsive disease in 2020; Adstiladrin (nadofaragene firadenovec), a gene therapy placed in the bladder every three months, with five-year data showing durable bladder preservation; and Anktiva (nogapendekin alfa inbakicept), which is given alongside BCG to boost the immune response and produced a complete response in 71% of patients in its trial.

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More options may be on the way. Cretostimogene, an investigational therapy that uses an engineered virus to attack cancer cells, has received FDA breakthrough therapy and fast track designations after a phase 3 trial showed a complete response rate of about 76%.

No single option is right for everyone, and bladder removal remains a valid choice for some patients. If BCG isn’t working for you, consider asking your doctor: Is my cancer considered BCG-unresponsive, and what type of tumor do I have? Which bladder-sparing treatments am I eligible for? Are there clinical trials, like SunRISe-5, that I might qualify for? What are the risks of trying another treatment versus having surgery now?

As Delahoussaye’s story shows, a failed first treatment doesn’t have to mean losing your bladder.

Building a Bladder Cancer Treatment Plan With Your Doctor

Your bladder cancer treatment depends on your tumor type, the stage of the disease, and your overall health, as well as your personal wishes and values. Your doctor is often part of a team that may include surgeons, urologists, medical and radiation oncologists, and pathologists. Before making any decision, it helps to write down your goals, concerns, and questions.

Here’s a general guide for that conversation:

• Know your cancer’s stage and grade. Stage describes how deep the cancer has grown and whether it has spread, while grade describes how aggressive it looks. “For stage, what we’re talking about is the depth of the cancer,” Dr. Jay Shah, associate professor of urology at Stanford University, previously told SurvivorNet. “High-grade means it looks more aggressive to the pathologist under the microscope.” Earlier-stage cancers are more likely to be cured, while later stages may need chemotherapy or other medications along with surgery.

• Understand what type of cell is cancerous. Most bladder cancers are urothelial cancers, which start in the cells lining the bladder. A biopsy lets your team examine the cells and choose the treatments most likely to work.
• Learn your treatment options. Surgery is the most common treatment, sometimes followed by chemotherapy or radiation, while targeted therapy and immunotherapy may be options for some patients. Ask how many visits or procedures each requires, what it will cost, and how often you’ll need follow-up.
• Weigh the risks and side effects. Each treatment carries different side effects, and your age and overall health affect which is best for you. Knowing what to expect can ease fears and help you plan.
• Set your treatment goals. Your goals might be a quick recovery, longer survival, staying at work, or maintaining a certain quality of life. Share them early so your team can work toward them.
• Decide together, and consider other perspectives. Ask why your team recommends certain treatments, whether you qualify for any clinical trials, and whether a second opinion from another bladder cancer expert could help.

Dealing With Your Bladder Cancer Diagnosis

Contributing: SurvivorNet Staff

Learn more about SurvivorNet's rigorous medical review process.

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