UroGen Pharma Ltd. (NASDAQ: URGN), a biotech company specializing in urothelial and specialty cancer treatments, announced today that the U.S. Food and Drug Administration (FDA) has set a meeting for May 21, 2025, to discuss the new drug application for UGN-102, a potential treatment for bladder cancer.
The FDA’s Oncologic Drugs Advisory Committee (ODAC) will review data for UGN-102 (mitomycin) for intravesical solution, which is under investigation for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The ODAC’s role is to provide independent expert advice to the FDA, but the agency is not obligated to follow the committee’s recommendations.
UGN-102 is a formulation of mitomycin using UroGen’s proprietary RTGel technology, intended to allow prolonged exposure of bladder tissue to the drug and offer a non-surgical treatment option. The application is supported by the Phase 3 ENVISION trial, which showed a 79.6% complete response rate at three months post-treatment and an 82.5% duration of response at 12 months.
The FDA plans to decide on the approval of UGN-102 by the Prescription Drug User Fee Act (PDUFA) target date of June 13, 2025. Liz Barrett, President and CEO of UroGen, expressed optimism about presenting their data and the potential benefits of UGN-102 for patients with bladder cancer.
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