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FDA approves new medication to treat bladder cancer

A surgeon holding a bladder image

Each year, thousands of people are diagnosed with recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer (LG-IR-NMIBC), a type of cancer of the bladder lining. Now, a new, FDA-approved medication from UroGen Pharma called ZUSDURI offers the opportunity to treat adults with recurrent forms of this cancer — without the need for further surgery.

Sandip Prasad, MD, a urologic oncologist at Atlantic Health, and surgical director of genitourinary oncology at Morristown Medical Center, shares more about this breakthrough medication, trialed at Atlantic Health, and how it can help thousands of patients experiencing this type of bladder cancer.

A safe alternative to cancer surgery

LG-IR-NMIBC impacts roughly 82,000 patients every year, but nearly 59,000 of those patients are experiencing recurrent cancer. Previously, guidelines for standard treatments indicated a surgical procedure called transurethral resection of bladder tumor (TURBT).

With so many patients experiencing recurrent bladder cancer, especially for LG-IR-NMIBC, that often means repeated surgeries done under general anesthesia. Unfortunately, given that patients experiencing bladder cancer tend to be older — the average age at diagnosis is 73 years old — and with other health conditions, repeated surgeries can often present increased health risks.

“For decades, TURBT has been the standard approach for bladder cancer treatment,” says Dr. Prasad. “That’s why innovative treatments like ZUSDURI are essential, especially for those adult patients with recurrent LG-IR-NMIBC.”

Hope for patients with recurrent cancer

Dr. Prasad was the principal investigator of the ENVISION trial, the Phase 3 trial that led to FDA approval for ZUSDURI. During this trial, for which Morristown Medical Center was a key site of patient recruitment, this new treatment demonstrated complete remission for 78% of patients at three months without the use of surgery. Of those patients in complete remission, 79% remained cancer-free a year later.

ZUSDURI offers a safe alternative to repeated surgeries for patients with LG-IR-NMIBC. This prescription medicine is approved for adults whose cancer has returned after having surgery to remove their tumor and helps ablate or eliminate the bladder cancer.

"This medication marks a breakthrough in uro-oncology, offering a new alternative for recurrent LG-IR-NMIBC patients who can live for many years with the disease but often endure multiple resections,” says Dr. Prasad.

For these patients, health care providers deliver this medicine directly into the bladder through a urinary catheter during an outpatient procedure or in the office. Patients receive one dose per week for six weeks and most experience limited, mild or moderate side effects.

“We’re proud that Atlantic Health could be part of this trial and appreciate the work of our cancer care and research teams in bringing this study to life,” says Dr. Prasad. “Most of all, we’d like to thank all the patients who participated and made this study possible.”

Published: July 22, 2025

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