UroGen Pharma’s Zusduri (mitomycin) has continued to show benefit after two years in patients with non-muscular invasive bladder cancer (NMIBC).
In the Phase III ENVISION trial (NCT05243550), duration of response (DOR) was maintained after two years in 72.2% of the 79.6% of low-grade, intermediate risk (LG-IR) NMIBC patients that achieved a complete response (CR) rate after three months, as determined by a Kaplan-Meier estimate.
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Following Zusduri’s approval for LG-IR-NMIBC in June 2025, the therapy has become the only non-surgical option for patients with the condition, paving the way for its notable growth – with GlobalData analysts estimating that the drug will hit sales of $449m in 2031.
GlobalData is the parent company of Clinical Trials Arena.
Dr. Sandip Prasad, director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center, said: “This DOR result highlights the sustained efficacy of the therapy and reinforces its potential as a durable treatment option. For the first time, adult patients with recurrent LG-IR-NMIBC have an FDA-approved therapy. This marks a potentially transformative step forward in how we manage this chronic, highly recurrent, and disruptive cancer.”
Being the only drug approved for LG-IR-NMIBC, Zusduri will sidestep competition from hard-hitters like MSD’s Keytruda (pembrolizumab) and Ferring Pharmaceuticals’ gene therapy Adstiladrin (nadofaragene firadenovec), which are only approved for use in high-risk, Bacillus Calmette-Guérin (BCG)-resistant patients.
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By GlobalDataMSD, known in the US as Merck, may also be set to take an even larger chunk of the high-risk market with the Phase III KEYNOTE-676 trial (NCT03711032) involving Keytruda set to read out later this year.
Johnson & Johnson’s Balversa (erdafitinib) is also in the running for LG-IR-NMIBC glory, with the MoonRISe-3 trial (NCT06319820) reading out by 2027, suggesting Zusduri’s commercial success could lie in the balance.
The BCG ‘elephant in the room’
The BCG vaccine was found to be beneficial in high risk NMIBC in the 1980s and has played a fundamental role in the indication’s treatment paradigm for more than 40 years.
Due to its widespread usage in high risk-NMIBC as standard of care (SoC) treatment and a tuberculosis (TB) vaccine, there has been a notable shortage of the vaccine for years, with sole manufacturer MSD struggling to keep up with demand.
To ensure availability of the BCG vaccine, the big pharma has begun construction of a dedicated manufacturing facility at its Durham, North Carolina site, which will likely be completed by the end of 2026, MSD confirmed in an email.
This phenomenon will likely impact all players in the NMIBC space, as beyond surgery, the BCG vaccine is currently the gold standard treatment for this indication.
Editor’s comment: Some changes have been made to the body of this article to remove reference to the investigation of UroGen’s therapy being used as a combination therapy.
