Application for Approval of Opdivo as Adjuvant Treatment for Urothelial Carcinoma
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On March 31, 2021, Ono Pharmaceutical announced the submission of an application for supplemental approval of Opdivo (nivolumab) as an adjuvant treatment for patients with urothelial carcinoma.
This application is based on the results of the Phase 3 CheckMate-274 (ONO-4538-33) trial. This trial randomized patients with muscle-invasive urothelial carcinoma at high risk of recurrence after surgery 1:1 to receive either Opdivo monotherapy (240 mg every two weeks) as adjuvant therapy or a placebo. The primary endpoint of disease-free survival (DFS) showed significant improvement in both the overall population and patients with PD-L1 expression of 1% or higher in the Opdivo group.
Clinical trials for Opdivo are also underway for other indications, including esophageal cancer, gastric cancer, liver cancer, urothelial carcinoma, ovarian cancer, bladder cancer, prostate cancer, pancreatic cancer, and biliary tract cancer.
Source: https://www.ono.co.jp/news/20210331.html
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