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Priority Review Accepted by FDA for Nivolumab in Adjuvant Treatment of Muscle-Invasive Urothelial Cancer

By: JNCCN 360 Staff
Posted: Tuesday, May 4, 2021

On April 30, Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application for nivolumab (Opdivo) for the adjuvant treatment of patients with surgically resected, high-risk, muscle-invasive urothelial carcinoma. The FDA assigned a target action date of September 3, 2021. If approved, nivolumab would be the first adjuvant immunotherapy option for this patient population in the United States.

This application is based on results from the phase III CheckMate 274 trial. In this study of 709 patients with muscle-invasive urothelial cancer at a high risk of recurrence after radical surgery, nivolumab or placebo was given every 2 weeks for up to 1 year. At the 2021 Genitourinary Cancers Symposium, investigators reported that nivolumab demonstrated a statistically significant increase in disease-free survival versus placebo (21 vs. 10.9 months), regardless of patients’ PD-L1 expression levels. The safety profile of nivolumab in this trial was noted to be consistent with that previously reported with the agent in patients with solid tumors (ie, melanoma, esophageal/gastroesophageal junction cancer, and non–small cell lung cancer).



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