FDA Accepts UroGen’s New Drug Application for UGN-102 — A Potential Game-Changer In Cancer Treatment
UroGen Pharma's UGN-102 receives FDA acceptance for NDA, aiming to be the first treatment for low-grade bladder cancer.
Breaking News
Oct 16, 2024
Simantini Singh Deo

UroGen Pharma Ltd., a biotechnology company focused on advancing treatments for urothelial and specialty cancers, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for UGN-102 (mitomycin), an investigational intravesical solution. If approved, UGN-102 would be the first FDA-sanctioned treatment for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) for June 13, 2025.
Liz Barrett, President and Chief Executive Officer of UroGen, said in a statement, "The FDA acceptance of our NDA is a pivotal moment in our journey to bring UGN-102 to patients. UGN-102 could be the first FDA-approved medicine for LG-IR-NMIBC, offering a novel approach that could expand treatment options and address unmet needs. There is an urgent need for innovative solutions in this space, and we are dedicated to collaborating with the FDA as we prepare for a potential launch of UGN-102 in 2025.”
Dr. Mark Schoenberg, Chief Medical Officer of UroGen, stated, “The NDA for UGN-102 is backed by a robust data set demonstrating impressive durability of response across three clinical trials and a favorable safety profile. Notably, the ENVISION trial successfully met its primary endpoint, showing a 79.6% complete response rate at three months after the first instillation of UGN-102. Additionally, the latest results from that trial revealed an 82.3% 12-month duration of response by Kaplan-Meier estimate in patients who achieved a complete response at 3 months.
He further continued, “The most common treatment-emergent adverse events in the ENVISION trial were dysuria, hematuria, urinary tract infection, pollakiuria, fatigue, and urinary retention. Additionally, the safety profile observed in the ENVISION trial was consistent with that seen in other studies of UGN-102. We believe that, if approved, UGN-102’s ability to achieve durable complete responses and potentially reduce recurrence rates while extending treatment-free intervals will represent a significant advance in managing LG-IR-NMIBC.”