FDA Accepts NDA for UGN-103 in Recurrent Low-Grade Intermediate-Risk NMIBC

The FDA accepted the New Drug Application for UGN-103, a next-generation intravesical mitomycin formulation for recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC), with a PDUFA date set for June 14, 2027. The NDA is supported by positive phase 3 UTOPIA trial data showing high complete response rates, and UGN-103 offers manufacturing and clinical use advantages over the prior mitomycin product Zusduri.

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