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FDA Approves Nivolumab for Urothelial Carcinoma

Published: Thursday, Feb 02, 2017

Jonathan E. Rosenberg, MD

Jonathan E. Rosenberg, MD

The FDA has granted an accelerated approval to nivolumab (Opdivo) as a treatment for patients with locally advanced unresectable or metastatic urothelial carcinoma following progression on a platinum-containing therapy, based on findings from a phase II CheckMate-275 study.

In June 2016, the FDA granted nivolumab a breakthrough therapy designation for the treatment of patients with unresectable locally advanced or metastatic urothelial carcinoma after the failure of a platinum-containing regimen. The EMA validated a type II variation application for use of nivolumab for the same indication in September 2016.
Galsky MD, Retz M, Siefker-Radtke AO, et al. Efficacy and safety of nivolumab monotherapy in patients with metastatic urothelial cancer (mUC) who have received prior treatment: Results from the phase II CheckMate-275 study. Presented at: 2016 ESMO Congress; October 7-11, 2016; Copenhagen, Denmark. Abstract LBA31.

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