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# Guide on BCG-unresponsive Nonmuscle Bladder Cancer
- URL: https://www.fdaweb.com/guide-on-bcg-unresponsive-nonmuscle-bladder-cancer/
- Published: 2018-02-12T12:00:00.000Z
- Updated: 2026-09-14T23:21:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140731

FDA has released a [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM529600.pdf?ref=fdaweb.com) on *Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment* that is intended to assist sponsors with pathological diagnosis and staging, risk stratification, and trial design, including assessment of appropriate clinical endpoints. These issues were discussed at an FDA/American Urological Association Bladder Cancer Workshop held in 2013\. The agency notes that many of the general principles discussed also apply to developing drugs for other forms of nonmuscle invasive bladder cancer.