FDA greenlights UroGen’s Zusduri for recurrent bladder cancer patients

The American medicines regulator has approved Zusduri (mitomycin), a hydrogel-based treatment developed by US biotech UroGen Pharma (Nasdaq: URGN), for adults with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

This makes Zusduri the first Food and Drug Administration (FDA)-approved medicine for this specific bladder cancer subtype, offering an alternative to repeated surgical procedures commonly required due to high recurrence rates.

The decision is based on results from the Phase III ENVISION trial, in which Zusduri demonstrated a 78% complete response rate at three months. Of those who initially responded, nearly four in five remained disease-free at 12 months.