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 intravesical therapy. In the case of NMIBC, the primary treatment choice involves combining intravesical chemotherapy with transurethral resection of the bladder, significantly reducing the disease and its recurrence. Commonly utilized chemotherapy agents include Mitomycin C, epirubicin, thiotepa, gemcitabine, and doxorubicin. Notably, Bacillus Calmette–Guerin (BCG) stands out as the most potent intravesical agent and is preferred for NMIBC patients with an intermediate and high risk of recurrence, as it is the sole agent with proven efficacy in delaying progression to muscle-invasive cancer.

However, the current Non-Muscle Invasive Bladder Cancer (NMIBC) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (TARA-002, OH2 injection, FE 999326, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Non-Muscle Invasive Bladder Cancer treatment. The key companies in the advanced development stage are Protara Therapeutics, Binhui Biopharmaceutical Co., Ltd., Ferring Pharmaceuticals, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Non-Muscle Invasive Bladder Cancer (NMIBC) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2023 to 2033.

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