Cancer Network

Intravesical Mitomycin Produces Enduring Efficacy Across NMIBC Trials

Data support the intravesical mitomycin solution’s role as an innovative option for those with recurrent, low-grade, intermediate-risk NMIBC. The intravesical mitomycin solution (Zusduri; formerly UGN ...
MPR

UGN-103 Under Review for Recurrent Low-Grade Intermediate-Risk NMIBC

The application for the next-generation mitomycin formulation is supported by 3-month complete response data from the phase 3 UTOPIA trial.
MedPage Today

Intravesical Mitomycin in Treatment of Non-Muscle-Invasive Bladder Cancer

In recent years the management of non-muscle-invasive bladder cancer has undergone radical changes. Intravesical Bacillus Calmette-Guérin (BCG) has long been established as the therapeutic standard ...
Targeted Oncology

FDA Accepts NDA for UGN-103 in Recurrent LG-IR-NMIBC

The FDA has accepted for review a new drug application (NDA) for UGN-103, an investigational intravesical formulation of ...
Business Wire

First Patient Dosed in Phase 3 Clinical Trial of UGN-103, a Next Generation Mitomycin-Based Formulation in Development for the Treatment of Low-Grade Intermediate-Risk Non ...

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, ...
Yahoo Finance

U.S. FDA Approves UroGen’s ZUSDURI™ (mitomycin) for Intravesical Solution as the First and Only Medication for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive ...

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Business Wire

UroGen Announces FDA Acceptance of Investigational New Drug Application for UGN-103, a Next Generation Mitomycin-Based Formulation for Low-Grade Intermediate-Risk Non-Muscle ...

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today ...
ascopubs.org

Intracutaneous and Intravesical Immunotherapy With Keyhole Limpet Hemocyanin Compared With Intravesical Mitomycin in Patients With Non–Muscle-Invasive Bladder Cancer: Results ...

Despite current treatment after transurethral resection of a bladder tumor, recurrences and progression remain a problem. Keyhole limpet hemocyanin (KLH) was beneficial in earlier studies. In this ...
Nature

Electromotive mitomycin in superficial bladder cancer

In a recent randomized trial, electromotive intravesical administration of mitomycin before transurethral resection was shown to be effective in the prevention of bladder cancer recurrence. Although ...
Medical Xpress

Intravesical gemcitabine/docetaxel as an alternative therapy for patients with non-muscle-invasive bladder cancer

Bladder cancer is one of the more common cancers worldwide. It is considered a major health care problem with a high financial burden. Of these cases, 75% are non-muscle-invasive, which characterizes ...
Pharm Exec

FDA Approves UroGen Pharma’s Zusduri for Intravesical Solution in Recurrent Low-Grade, Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Approval of Zusduri was based on data from the Phase III ENVISION trial, which showed a 78% complete response at three months in patients with recurrent low-grade, intermediate-risk non-muscle ...