Approved Bladder Cancer Treatment: UroGen’s Zusduri Offers New Hope for Patients
In a landmark decision set to transform the treatment landscape for bladder cancer, the US Food and Drug Administration (FDA) has approved Zusduri™ (mitomycin intravesical solution), a novel therapy developed by UroGen Pharma, for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Delivered directly into the bladder through an out-patient intravesical procedure, Zusduri becomes the first and only FDA-approved medicine for this subset of bladder cancer patients – offering a long-awaited alternative to the repetitive surgeries many currently face.
A New Chapter in Bladder Cancer Treatment
Until now, patients diagnosed with LG-IR-NMIBC have had few choices beyond transurethral resection of bladder tumour (TURBT) – a surgical procedure typically performed under general anaesthesia.
Despite being the standard of care for decades, TURBT often needs to be repeated multiple times due to the high recurrence rate of the disease. Each year in the United States, approximately 59,000 patients with LG-IR-NMIBC experience a recurrence, making the need for a non-surgical treatment all the more urgent.
The president and CEO of UroGen, hailed the FDA’s green light as a defining moment for both the company and the broader bladder cancer community.
They stated that for the first time, US patients facing recurrent LG-IR-NMIBC have access to an FDA-approved medicine, emphasising the clinical and emotional burden that repeated surgeries place on patients and healthcare systems alike.
Clinical Breakthrough Backed by Results
The FDA’s approval of Zusduri was underpinned by the positive findings of UroGen’s phase 3 ENVISION trial.
According to the study, Zusduri achieved a 78% complete response rate at three months, meaning that nearly four out of five patients saw no evidence of cancer. Even more compelling, 79% of those responders remained event-free 12 months later, highlighting the potential of the drug to provide durable remission.
The principal investigator of the ENVISION trial, noted the significance of this milestone commenting that for decades, TURBT has been the mainstay of treatment for non-muscle invasive bladder cancer.
But the need for innovation is urgent – especially for adult patients dealing with repeated recurrences. Treatments like Zusduri are not just welcome – they are essential.
Conclusion: A Long-Awaited Advancement
The approval of Zusduri marks a significant leap forward in the treatment of bladder cancer, finally addressing a long-standing gap for patients suffering from recurrent LG-IR-NMIBC.
With strong clinical backing and a less invasive delivery method, Zusduri offers new hope to tens of thousands of patients in the US who have, until now, relied on repeated surgery to manage their disease.
For UroGen and the medical community, this milestone signals not just regulatory success – but a tangible step toward improved patient care and quality of life.
News Credits: FDA approves UroGen’s Zusduri to treat recurrent bladder cancer
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