Shots:
- The US FDA has approved Zusduri (mitomycin) for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC); expected to be available in the US by Jul 1, 2025
- Approval was based on P-III (ENVISION) trial assessing Zusduri (QW, intravesical) in ~240 LG-IR-NMIBC pts across 56 sites, which showed 78% pts achieved CR at 3mos., with 79% of those remaining event-free at 12mos.
- As a post-marketing commitment, UroGen will complete the ongoing ENVISION trial & provide the FDA with annual DoR updates for pts with ongoing CRs until recurrence, progression, death, loss to follow-up, or 63mos. post-first dose
Ref: Businesswire | Image: UroGen Pharma| Press Release
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