Non-Muscle Invasive Urothelial Carcinoma

NDA Granted to Investigational Mitomycin Formulation
The US Food and Drug Administration has accepted a New Drug Application for the investigational drug UGN-102 (mitomycin) from UroGen Pharma as an intravesical therapy. UGN-102 could become the first FDA-approved therapy for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The mechanism of action for UGN-102 involves a sustained-released hydrogel formulation of mitomycin that allows for longer exposure of bladder tissue to the drug, potentially sparing patients from surgical intervention. ...
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