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A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence

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Trial Profile

A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Jun 2025

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At a glance

  • Drugs Mitomycin (Primary)
  • Indications Bladder cancer; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ENVISION
  • Sponsors UroGen Pharma

Most Recent Events

  • 12 Jun 2025 According to an UroGen Pharma media release, based on data from this study, the U.S. FDA approved ZUSDURI, the first and only FDA-approved medication for adults with recurrent LG-IR-NMIBC.
  • 02 Jun 2025 According to an UroGen Pharma media release, data from this study presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.
  • 21 May 2025 According to an UroGen Pharma media release, company announced the outcome of meeting of the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA), which discussed the new drug application (NDA) for investigational drug UGN-102 (mitomycin) for intravesical solution. By a narrow margin, the ODAC voted 4 to 5 that the benefit/risk of UGN-102 (mitomycin) for intravesical solution was favorable for the treatment of recurrent LG-IR-NMIBC. The FDA carefully considers

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