UroGen Pharma Receives U.S. FDA Approval for ZUSDURI™ as First Treatment for Recurrent LG-IR-NMIBC
Friday, June 13, 2025
UroGen Pharma has received approval from the U.S. Food and Drug Administration (FDA) for ZUSDURI™ (mitomycin) for intravesical use, marking it as the first and only approved treatment for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
ZUSDURI is administered by a healthcare professional in an outpatient setting using a urinary catheter. The formulation allows for the slow release of mitomycin within the bladder, enabling targeted treatment without surgery.
Non-muscle invasive bladder cancer affects approximately 82,000 individuals in the U.S. annually, with around 59,000 of these being recurrent cases. Most patients are diagnosed later in life and may face multiple recurrences, making non-surgical alternatives particularly valuable.
The treatment uses the company’s proprietary RTGel® technology to deliver mitomycin directly into the bladder, offering a non-surgical alternative to repeated transurethral resections commonly required for this patient group.
ZUSDURI combines mitomycin with a sterile hydrogel and is delivered using UroGen’s proprietary sustained-release RTGel® technology. It is specifically designed for tumour ablation and provides a non-surgical treatment option for patients who would otherwise require repeat procedures under general anaesthesia.
The approval is based on data from the Phase 3 ENVISION trial, which showed a complete response in 78% of patients after three months. Among those who responded, 79% remained event-free after 12 months.
LG-IR-NMIBC is usually treated with a surgical procedure known as transurethral resection of bladder tumour (TURBT). Due to the high recurrence rate of this type of bladder cancer, patients often undergo multiple TURBT procedures over time. ZUSDURI offers an alternative to this repeated surgical intervention.
The most commonly reported side effects (≥10%) include elevated creatinine and potassium levels, urinary discomfort, reduced haemoglobin, liver enzyme changes, urinary tract infections, and blood in the urine. Serious adverse events were reported in 12% of patients, including urinary retention and urethral narrowing.
In preparation, UroGen has plans to launch a dedicated patient website and support services aimed at helping patients access the treatment. These services may include assistance with insurance coverage and financial support for eligible individuals.
ZUSDURI is expected to be commercially available in the U.S. by early July 2025.
Source: urogen.com
