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AUGUST 27, 2021

FDA Expands Opdivo Label to Include Adjuvant Treatment of UC

The FDA approved nivolumab (Opdivo, Bristol Myers Squibb) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk for recurrence after radical resection.

This is the first FDA approval for adjuvant treatment of patients with high-risk UC. The results supporting this approval also supported the conversion of nivolumab’s accelerated approval for advanced/metastatic UC to a regular approval.

“This approval is a major milestone for patients who have