medwireNews: The EMA recommends expanding the indication for nivolumab monotherapy to include the adjuvant treatment of PD-L1-positive, high-risk muscle-invasive urothelial carcinoma (MIUC).
The regulatory agency states that the PD-1 inhibitor should be used in adults with tumor cell PD-L1 expression levels of at least 1% and a high risk for recurrence after radical surgery.
This decision follows the approval of nivolumab in this setting by the US FDA in August 2021, and is based on the results of the CheckMate 274 trial showing a significant disease-free survival benefit with the adjuvant use of nivolumab versus placebo.
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