FDA Accepts UroGen's NDA for UGN-102, Potential First Treatment for LG-IR-NMIBC
UroGen Pharma Ltd., a biotech company developing and commercializing innovative solutions for urothelial and specialty cancers, has announced the FDA acceptance of the New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution. UGN-102 could become the first FDA-approved medicine for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 13, 2025. Publish Date: 15-10-2024 Source: UroGen Pharma Ltd. Non-muscle invasive bladder cancer (NMIBC) comprises the majority, approximately 80%, of all bladder cancer cases. Among NMIBC, Ta bladder cancer represents the most prevalent subtype, accounting for 60%, while T1 and carcinoma in situ (CIS) comprise the remaining 30% and 10%, respectively. Effective management of NMIBC hinges on two fundamental principles: complete transurethral resection (TUR) of the bladder tumor (TUR-B) and intrav...