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23-08-2021 | FDA | News

approvalsWatch

FDA recommends adjuvant nivolumab for high-risk urothelial carcinoma

Author:
Hannah Kitt

medwireNews: Patients with urothelial carcinoma who have a high risk for recurrence following radical resection may be given nivolumab in the adjuvant setting, the US FDA has announced.

This decision is based on interim results of the phase 3 CheckMate 274 trial, demonstrating a significant disease-free survival (DFS) benefit with adjuvant nivolumab relative to placebo in this patient population, such that in the intention-to-treat analysis the risk for first recurrence or death was 30% lower with the PD-1 inhibitor. The median DFS times in the nivolumab and placebo groups were 20.8 and 10.8 months, respectively.

It is recommended that nivolumab be administered at a dose of 240 mg every 2 weeks or 480 mg every 4 weeks.

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