FDA Approves UroGen’s Chemo-Turned-Gel Drug ZUSDURI Despite Negative Advisory Vote

The FDA has approved UroGen's ZUSDURI (mitomycin gel) for the treatment of adults with recurrent low-grade, intermediate-risk non–muscle-invasive bladder cancer (LG-IR-NMIBC), making it the first and only medication specifically for this indication3.

This approval came as a surprise because the FDA's Oncology Drug Advisory Committee (ODAC) voted 5 to 4 against the risk/benefit profile of UroGen’s UGN-102 (now branded as ZUSDURI)5.

ODAC members were concerned about the lack of a randomized trial, limited long-term follow-up, and potential biases in the pivotal ENVISION Phase 3 single-arm trial, which was used to support the approval5.

Despite the negative vote and expressed concerns about efficacy interpretation and lack of comparative safety data, the FDA moved forward with approval. ZUSDURI is expected to be available in the U.S. around July 1, 20253.

Sources:

3. https://investors.urogen.com/news-releases/news-release-details/us-fda-approves-urogens-zusduritm-mitomycin-intravesical

5. https://www.prnewswire.com/news-releases/urogen-pharma-ltd-urgn-shares-crash-again-amid-fdas-odac-vote-against-ugn-102-company-facing-investor-scrutiny--hagens-berman-302468703.html