FDA Approves UroGen's Zusduri As First Drug For Recurrent Bladder Cancer

The U.S. Food and Drug Administration (FDA) on Thursday approved UroGen Pharma Ltd.’s URGN Zusduri, the first and only FDA-approved medication for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

Zusduri consists of mitomycin and sterile hydrogel, using UroGen’s proprietary sustained-release RTGel technology. Zusduri has been designed to treat potent tumor ablation.

The FDA approval is based on the results from the Phase 3 ENVISION trial, which demonstrated that Zusduri delivers 78% complete response (CR) for patients at 3 months, and of those patients, 79% remained event-free 12 months later.

Also Read: UroGen Pharma Stock Receives Downgrade As Analyst Cites FDA Panel Setback For Key Bladder Cancer Drug

The existing standard of care for LG-IR-NMIBC is a surgical procedure typically performed under general anesthesia called transurethral resection of bladder tumor (TURBT). Due to high recurrence rates of LG-IR-NMIBC, repeat TURBTs may be necessary.

Zusduri is expected to be available in the U.S. on or around July 1, 2025, for adults with recurrent LG-IR-NMIBC.

In May, the FDA’s Oncologic Drugs Advisory Committee voted against the benefit/risk of UGN-102 (mitomycin) for an intravesical solution.

The committee voted four yes to five no that the benefit/risk of UGN-102 for intravesical solution was favorable for recurrent LG-IR-NMIBC.

The vote comes after the committee reviewed clinical data supporting the efficacy and safety of UGN-102, including the results from the Phase 3 ENVISION study.

In April, UroGen Pharma highlighted a duration of response of nearly four years from a long-term follow-up study with Jelmyto (mitomycin) for pyelocalyceal solution.

The FDA approved Jelmyto in 2020 for low-grade upper tract urothelial cancer (LG-UTUC) in adults.

Among patients from the OLYMPUS trial who achieved a complete response after primary chemoablation with Jelmyto (n = 41), the median duration of response was 47.8 months, regardless of whether their cancer was new onset or recurrent (median follow-up, 28.1 months).

Price Action: URGN stock is up 9.61% at $12.15 at the last check on Friday.

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