Back to today’s briefing

Story perspectives

FDA Approves First Treatment for Non-Muscle-Invasive Bladder Cancer

6/13/2025

49 10

Summary

Story summary

The FDA has made a groundbreaking decision by approving intravesical mitomycin (UGN-102) for low-grade, intermediate-risk non-muscle-invasive bladder cancer, a first in its category. Backed by the promising ENVISION trial, which revealed an impressive 80% complete response rate at three months, the approval comes amid caution from the FDA's advisory committee regarding the treatment's overall benefit-risk balance.

1 of 1

Story summary

The FDA has made a groundbreaking decision by approving intravesical mitomycin (UGN-102) for low-grade, intermediate-risk non-muscle-invasive bladder cancer, a first in its category. Backed by the promising ENVISION trial, which revealed an impressive 80% complete response rate at three months, the approval comes amid caution from the FDA's advisory committee regarding the treatment's overall benefit-risk balance.