UroGen Pharma Reports P-III Trials (ATLAS) and (ENVISION) Results of UGN-102 as First Non-Surgical Therapy for Non-Muscle Invasive Bladder Cancer
Shots:
- The company highlighted the P-III trials (ATLAS) at clinical sites in the US, EU & Israel, and (ENVISION) across 56 sites evaluating UGN-102 in 282 & 240 patients
- The (ATLAS) study met its 1EPs of DFS, 55% reduction in risk of recurrence, progression, or death, CR rate at 3mos. (64.8% for UGN-102 vs 63.6% for TURBT) & demonstrated superiority to TURBT. The (ENVISION) trial also met its 1EPs & showed a 79.2% CR rate at 3mos., following the initial treatment while additional data evaluates the EPs of DoR
- The results showed a robust & consistent therapeutic profile across multiple clinical trials, was well tolerated with a side effect profile similar to prior trials. The company is expected to submit an NDA to the FDA in 2024, based on the P-III study (ENVISION) results
Ref: UroGen Pharma | Image: UroGen Pharma
Related News:- UroGen Initiates P-III (ENVISION) Study of UGN-102 for the Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
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