FDA Approves UroGen's UGN-102 NDA for Bladder Cancer

UroGen Pharma has announced that its New Drug Application (NDA) for UGN-102 (mitomycin) has been accepted by the US Food and Drug Administration (FDA). This medication is designed for intravesical administration, meaning it is directly administered into the bladder to treat low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

UGN-102 is a formulation of mitomycin that incorporates UroGen's RTGel technology. This innovative technology enables a hydrogel-based formulation with reverse-thermal properties, allowing for a sustained release of the drug. The main aim of UGN-102 is to extend the bladder tissue's exposure to mitomycin, thereby enabling non-surgical treatment of tumors.

Bladder cancer is recognized as the second most common urologic cancer among men in the United States, predominantly affecting the older population.

Liz Barrett, who serves as the president and CEO of UroGen, stated, “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.”

The NDA submission is backed by data from three clinical trials, illustrating the durability of the drug's response and highlighting its safety profile. One of the key studies, the Phase III multinational, single-arm, multicenter ENVISION study, achieved its primary endpoint with a 79.6% complete response rate three months after the initial administration of UGN-102. Additionally, the study revealed an 82.3% duration of response over 12 months, as estimated by the Kaplan-Meier method in subjects who had a complete response at three months. The safety profile of UGN-102 has been found to be consistent with other studies of the drug.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of June 13, 2025, for the review of the NDA for UGN-102. A decision regarding the approval of the drug is expected by this date.