UroGen Reports the US FDA’s NDA Acceptance of Mitomycin (UGN-102) for Treating Non-Muscle Invasive Bladder Cancer
Shots:
- The US FDA has accepted the NDA of mitomycin as intravesical solution for treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), with the decision expected on Jun 13, 2025 & launch in the same year
- Submission was based on P-III (ENVISION) trial assessing the safety & efficacy of mitomycin intravesical solution as primary chemoablative therapy to treat LG-IR-NMIBC patients (n=240), receiving 6 instillations (QW)
- Study achieved its 1EP, demonstrating CRR of 79.6% at 3mos. post first instillation, with 12mos. DoR of 82.3% in these patients. Safety profile was similar to the previous trials, with most common TEAEs being dysuria, hematuria, urinary tract infection, pollakiuria, fatigue & urinary retention
Ref: Urogen | Image: Urogen
Related News:- UroGen Pharma Reports P-III Trial (ATLAS) Results of UGN-102 for Low-Grade, Intermediate-Risk Non-Muscle Invasive Bladder Cancer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
