The U.S. Food and Drug Administration (FDA) on Thursday approved UroGen Pharma Ltd.’s (NASDAQ: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.

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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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