PEOPLE WITH NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) often face a frustrating cycle: surgery to remove tumors, followed by months of monitoring, then more surgery when the cancer returns. But two new treatments approved in 2025 offer options for patients to delay or avoid repeated trips to the operating room.

People with NMIBC, which is cancer contained inside the bladder, often undergo transurethral resection of bladder tumor (TURBT) to remove small tumors. This procedure involves general anesthesia while surgeons use a scope and small wire loop to remove visible tumors through the urethra. “These patients are going back and forth to the operating room, and it’s a real big deal,” says Siamak Daneshmand, a urologic oncologist at USC Norris Comprehensive Cancer Center in Los Angeles.

After TURBT, patients often receive single-dose chemotherapy or bacillus Calmette–Guérin (BCG), a form of immunotherapy, delivered directly to the bladder via catheter—an approach that is called intravesical therapy. But when cancer stops responding to these approaches, other options can deliver chemotherapy directly into the bladder.

On Sept. 9, 2025, the Food and Drug Administration (FDA) approved Inlexzo, a gemcitabine intravesical system. The small, pretzel-shaped device, which is about the size of two quarters, is placed directly in the bladder through a catheter and slowly releases gemcitabine over three weeks. The device was approved for adults with NMIBC that has not responded to BCG therapy.

In the study that led to the FDA approval, 83 people with BCG-unresponsive high-risk NMIBC received Inlexzo. Eighty-two percent of the patients had a complete response—with 51% maintaining that response for at least one year. Additional data from the trial revealed that patients maintained a response for a median of 25.8 months, and 96% of patients’ cancer went away within the first three months of treatment.

This approach provides an additional option to control bladder cancer when it has stopped responding to treatment. “The key for Inlexzo is bladder preservation because the next step potentially would be bladder removal,” Daneshmand says.

The in-office procedure to place the device takes about 10 minutes, Daneshmand says. Patients return to have the device removed and replaced with a new device every three weeks for up to six months. Patients then return to the office to receive new devices every 12 weeks for up to an additional 18 months.

On June 12, 2025, the FDA also approved a medication called Zusduri for people with recurrent low-grade, intermediate-risk NMIBC. These cancers are typically slow-growing tumors that have a lower risk of progression. The medication, which is delivered directly to the bladder via a catheter, turns mitomycin chemotherapy into a reverse thermal gel that becomes sticky and adheres to the bladder wall for up to six hours—far longer than traditional intravesical treatments, which remain in the bladder for an hour or two.

In the trial leading to the FDA approval of Zusduri, 78% of the 223 patients had a complete response at three months, and 79% maintained that response for 12 months. A recent analysis showed that 72.2% of people continued to have a complete response at 24 months.

Zusduri could be an option for people with recurrent low-grade tumors who are not candidates for bladder removal or TURBT due to other health conditions, says Sandip Prasad, a urologic oncologist at Morristown Medical Center in New Jersey and the trial’s principal investigator.

In addition, patients can continue to take blood thinners while receiving Zusduri, but they would need to stop blood thinners before TURBT due to an increased bleeding risk. Like BCG, Zusduri is delivered via standard catheter in two to three minutes. Patients typically will lay down for 10 to 15 minutes for the medication to set in the bladder. Patients return once a week for six weeks to receive the treatment.

Side effects are generally mild and manageable. About one-quarter to one-third of patients experience temporary urinary symptoms, such as needing to urinate more often, urgency, burning with urination or blood in the urine, which often resolve on their own or with over-the-counter pain relievers.

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These treatments provide a way to control recurrence that is less invasive than surgery. “For us, it’s just a half-hour case. It’s not a big deal,” Daneshmand explains. “But for the patient, TURBT and other surgeries involve a much larger process involving general anesthesia.” In addition, many people with bladder cancer are older and take blood thinners, which can increase the risk of complications.

After TURBT, patients may experience urinary symptoms for days to weeks, including bleeding and severe burning. Some describe it as “urinating razor blades,” says Prasad. A full recovery can take anywhere from two to four weeks. With these newer approaches, patients can avoid having to undergo anesthesia, experience generally milder side effects and have minimal recovery time. These treatments can also provide patients some psychological relief. “It’s a really demoralizing thing” when tumors keep recurring, Prasad notes, even if they’re low-grade. These treatments offer a strategy shift rather than repeatedly doing the same surgery to remove tumors.

Radical cystectomy—complete bladder removal—remains an option for some people with NMIBC, especially high-risk cases that do not respond to BCG, recur or have aggressive disease. “These treatments are paradigm shifts in how we manage patients for both recurrent low-grade tumors, as well as high-grade NMIBC,” adds Daneshmand, emphasizing the importance of discussing these new options with a urologist to determine the best approach.