An innovative new treatment option for bladder cancer, recently approved by the U.S. Food and Drug Administration, has been performed for the first time in Maryland.

Dr. Heather Chalfin, a urological oncologist and surgeon at Frederick Health, recently administered Maryland’s first gemcitabine intravesical system, under the brand name Inlexzo, which was approved by the FDA in September.

“We call it ‘the pretzel,’ because it’s a device that curls up like a pretzel shape in someone’s bladder and releases chemotherapy over three weeks,” Chalfin told WTOP.

Until now, patients with bladder cancer that has not invaded the bladder muscle, but are unresponsive to immunotherapy called Bacillus Calmette-Guerin (oftentimes abbreviated BCG) — and have chosen not to have or are unable to have bladder removal surgery — have been treated with chemotherapy.

“The problem with that is patients can only spend about an hour with that chemotherapy in their bladder in our office,” Chalfin said.

With Inlexzo, made by Johnson & Johnson, the device remains in the bladder for three weeks per treatment cycle, for up to 14 cycles.

“And then they come back and we swap it out for a new ‘pretzel,’ as opposed to just having that chemotherapy active for only an hour inside the bladder,” Chalfin said.

In the SunRISe-1 clinical trial, 82% patients had no signs of cancer after treatment. Fifty-one percent of the patients stayed cancer-free for at least one year, while long-term survival data on the new device is still being gathered.

How ‘the pretzel’ works

Chalfin said the intravesical drug releasing system begins as a straight, springy device.

“The way we get it in is very similar to how we put in a urine catheter for many other situations, so it’s a very minimally invasive procedure,” Chalfin said.

Once the Inlexzo has been inserted, “A good way to think about is if you think about a Slinky — if you pull it a Slinky, it becomes straight, but then when you release it, it curls back up into a Slinky,” she said.

Every three weeks, the Inlexzo is replaced with another one.

“It’s a simple procedure that bladder cancer patients are already having regularly, which is called a cystoscopy, or a camera in the bladder,” Chalfin said.

The procedure is done in the office, and patients go home the same day, Chalfin said.

According to Frederick Health, 9,471 new cases of bladder cancer are diagnosed each year. The National Cancer Institute projects there will be almost 85,000 new bladder cancer diagnoses and approximately 17,420 deaths from bladder cancer in the U.S. in 2025, making it the sixth most common cancer in the U.S.

In addition to Inlexzo, Frederick Health is using blue-light cystoscopy technology, which enhances the visibility of certain bladder tumors that may have been missed with a traditional white light cystoscopy. The advancement improves detection rates, especially for early-stage or hard-to-see cancers.

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