UroGen Pharma Ltd., a biotech company specializing in treatments for urothelial and specialty cancers, has announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has reviewed their new drug application (NDA) for UGN-102 (mitomycin) for intravesical solution. The committee narrowly voted 4 to 5 against the benefit/risk profile of UGN-102 as favorable for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). Despite this, UroGen remains optimistic about their clinical data and is committed to working with the FDA as the NDA continues under review. The FDA's final decision is expected by June 13, 2025, per the Prescription Drug User Fee Act (PDUFA) timeline.
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