At the beginning of June, the Food and Drug Administration (FDA) approved Zusduri (mitomycin intravesical solution) for non-invasive bladder cancer patients whose disease recurred (as low-grade intermediate-risk), following transurethral resection (TUR) of a bladder tumor.
Zusduri is a special form of mitomycin. It is instilled into the bladder as a liquid through a urinary catheter. Once in the bladder, the warmer temperature turns it into gel that stays in contact with the bladder wall for several hours (ACS).
The study aim was to investigate Zusduri as an effective alternative option to TUR.
The approval was based on results from a clinical trial which included 240 patients. Patients were recruited if their tumor recurrence met 1-2 of the following criteria: multiple tumors, a solitary tumor >3 cm, and/or recurrence within 1 year.
Participants received Zusdari once a week for 6 consecutive weeks. Assessment of tumor status was performed every 3 months by cystoscopy and urine cytology.
At 3 months (first follow-up) almost 80% had no detectable disease by cystoscopy and urine cytology (i.e complete response). Almost 80% of responding patients remained in a similar situation for at least 12 months.
Among the most common side effects observed, were urinary tract infections and laboratory abnormalities.
Zusduri offers a promising treatment option for patients with recurrent low-grade intermediate-risk bladder cancer.