PRINCETON, N.J.– UroGen Pharma (NASDAQ: URGN) announced that the U.S. Food and Drug Administration (FDA) has scheduled a meeting of the Oncologic Drugs Advisory Committee (ODAC) for May 21 to review its investigational therapy UGN-102, a potential treatment for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
The advisory committee meeting will provide independent experts and clinicians an opportunity to assess the clinical data supporting UGN-102 and offer a recommendation on its approval. While the FDA considers ODAC’s input carefully, the agency is not required to follow its advice. The FDA has indicated it plans to complete its review by the Prescription Drug User Fee Act (PDUFA) target date of June 13, 2025.
UGN-102 is a novel formulation of mitomycin designed for intravesical delivery using UroGen’s proprietary RTGel® technology. The drug is intended as a non-surgical treatment option for patients with recurrent LG-IR-NMIBC—a condition currently lacking FDA-approved therapies.
“We are excited to present our data to the Advisory Committee and engage with the broader medical community,” said Liz Barrett, President and CEO of UroGen. “We believe UGN-102 could offer a significant advancement for patients dealing with the burdens of recurrent bladder cancer.”
The company’s New Drug Application (NDA) is supported by results from the Phase 3 ENVISION trial, which reported a 79.6% complete response rate at three months following initial treatment. Among those who achieved complete response, 82.5% maintained that response at 12 months, based on Kaplan-Meier analysis.
UGN-102 is administered via a standard urinary catheter in an outpatient setting, enabling broader access and potentially reducing the need for repeated surgical interventions. The NDA was submitted ahead of schedule in August 2024 and accepted by the FDA later that year.
If approved, UGN-102 would become the first non-surgical drug therapy for patients with this form of bladder cancer.
