FDA Advisory Committee Narrowly Votes Against UroGen’s Bladder Cancer Drug, Calls for Further Studies

The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 5 to 4 against a favorable benefit-risk profile for UroGen Pharma's UGN-102 (mitomycin) for treating recurrent low-grade intermediate-risk non–muscle invasive bladder cancer (LG-IR-NMIBC)345.

The narrow vote reflected uncertainty about the sufficiency of evidence from existing studies, with the committee calling for randomized controlled trials (RCTs) to better establish the drug’s effectiveness and safety45.

The ODAC meeting reviewed data from the ENVISION trial, which enrolled 240 patients who received six once-weekly instillations of UGN-1024.

UGN-102 would be the first FDA-approved treatment specifically for LG-IR-NMIBC if approved, but further data is required before regulatory approval is considered4.

Although the FDA relies on ODAC's input, it is not bound by the committee's vote; the final decision remains with the agency, with a Prescription Drug User Fee Act (PDUFA) target action date of June 13, 20254.

Sources:

3. https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/urogens-bladder-cancer-drug-draws-split-decision-from-us-fda-panel-VKXLVQMLSJBKBOK3TZDQABSTNE/

4. https://www.urologytimes.com/view/live-updates-fda-advisory-committee-meeting-on-ugn-102-for-lg-ir-nmibc

5. https://endpts.com/fda-adcomm-narrowly-votes-against-urogens-bladder-cancer-drug/