UroGen Initiates P-III (ENVISION) Study of UGN-102 for the Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Shots:
- The P-III (ENVISION) study evaluates the efficacy & safety of UGN-102 (intravesical sol.) as primary chemoablative therapy in ~220 patients with NMIBC across 90 sites. The study is similar to P-IIb (OPTIMA II) study & patients will have the same clinical characteristics, treatment regimen, assessment & qualitative follow up with different EPs
- The 1EP is CRR @3mos. after 1st instillation & 2EPs will be durability in patients who achieve complete response at 3mos. assessment
- The company is planning to submit an NDA for UGN-102 in 2024. The company will continue to explore the benefits of chemoablation in other types of bladder cancer including high-grade disease & other specialty cancers
Ref: Businesswire | Image: Businesswire
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