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# Panel is Split on UroGen’s Bladder Cancer Drug
- URL: https://www.fdaweb.com/panel-is-split-on-urogens-bladder-cancer-drug/
- Published: 2025-05-21T12:00:00.000Z
- Updated: 2026-09-14T15:12:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159225

FDA’s Oncologic Drugs Advisory Committee 5/21 was split (4 yes votes to 5 no votes) in its voting on whether UroGen Pharma’s NDA for mitomycin intravesical solution demonstrated a favorable benefit-risk profile for treating adult patients with low-grade intermediate-risk non-muscle invasive bladder cancer. Case Western Reserve Cancer Center oncologist **Daniel Spratt** voted no and said that without a full randomized trial it is hard to determine mitomycin’s true benefit, adding that there was very limited long-term follow-up.

In voting yes, National Cancer Institute Urologic Oncology Branch associate director **Mark Ball** acknowledged that a fully enrolled, randomized clinical trial would have mitigated many critiques of mitomycin’s benefit-risk profile. Regardless, he said the company’s data demonstrated efficacy at three months, and that a nonsurgical intervention to treat this disease state and that the signal at 12 months and beyond, even though there are differences in the interpretation of the data, was quite encouraging.