> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# BMS’ Opdivo High Risk Urothelial Carcinoma OK’d
- URL: https://www.fdaweb.com/bms-opdivo-high-risk-urothelial-carcinoma-okd/
- Published: 2021-08-20T12:00:00.000Z
- Updated: 2026-09-14T17:11:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149979

*FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection.* This is the first FDA approval for adjuvant treatment of patients with high-risk UC, an [agency release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-urothelial-carcinoma?ref=fdaweb.com) says.

Approval was based on data from the company’s CHECKMATE-274 (NCT02632409) clinical trial, which also supported conversion of nivolumab’s accelerated approval for advanced/metastatic UC to a regular approval. “At a prespecified interim analysis, a statistically significant improvement in \[disease-free survival \] DFS was demonstrated in patients on the nivolumab arm vs. placebo,” FDA says.