HQ Team
June 13, 2025: UroGen Pharma Ltd.’s therapy to treat adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer has been approved by the US Food and Drug Administration.
The drug mitomycin, or branded as Zusduri, is an intravesical solution, a liquid drug or medication that is administered directly into the bladder, typically through a catheter inserted into the urethra.
This method allows the drug to come into direct contact with the bladder lining and its cells.
Efficacy was evaluated in a multicenter trial in 240 adults with low-grade non-muscle invasive bladder cancer that recurred after prior transurethral resection of bladder tumour and met one or two of the laid down criteria, according to an FDA statement.
78% of patients had complete response
The criteria involved multiple tumours, a solitary tumour greater than three centimeters, or recurrence within one year.
Patients received 75 mg mitomycin intravesical solution instilled once a week for six consecutive weeks. Assessment of tumour status was performed every three months by cystoscopy, for-cause biopsy, and urine cytology.
The major efficacy outcomes were complete response at three months — no detectable disease in the bladder by cystoscopy and urine cytology. If warranted, a biopsy was performed.
Among the 223 patients evaluable for response, 78% had a complete response. The duration of response ranged from zero to more than 25 months, and 79% of responding patients remained in response for at least a year.
One patient dies of cardiac failure
The most common adverse reactions, more than 10%, included laboratory abnormalities, such as increased creatinine, increased potassium, dysuria, decreased haemoglobin and lymphocytes, urinary tract infection, decreased neutrophils, and hematuria.
Serious adverse reactions occurred in 12% of patients, including urinary retention (0.8%) and urethral stenosis (0.4%). A fatal adverse reaction of cardiac failure occurred in one patient.
LG-IR-NMIBC affects around 82,000 people in the U.S. every year, and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years.
Zusduri consists of mitomycin and sterile hydrogel, using UroGen’s proprietary sustained release technology. It has been designed for potent tumour ablation.
‘FDA-approved medicine’
“The approval of ZUSDURI represents a significant step forward for our company and for the treatment of recurrent LG-IR-NMIBC,” said Liz Barrett, President and CEO of UroGen. “For the first time, the estimated 59,000 U.S. patients facing recurrent LG-IR-NMIBC each year have access to an FDA-approved medicine.”
The existing standard of care for LG-IR-NMIBC is a surgical procedure typically performed under general anaesthesia called transurethral resection of bladder tumour. Due to high recurrence rates of LG-IR-NMIBC, repeated surgeries may be necessary.
