The US Food and Drug Administration (FDA) today approved Opdivo, (nivolumab) for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during a period of up to 1 year after first-line platinum-containing chemotherapy.
Bladder cancer will be diagnosed in approximately 77,000 people in the United States this year alone. The average age that patients are diagnosed with bladder cancer is 70 years, with 80% of these patients being former smokers. The most common type of bladder cancer is urothelial carcinoma, whereby cancer begins in the cells that line the bladder.
The accelerated approval makes Opdivo,, which is a programmed cell death receptor–1 inhibitor, the second immunotherapy approved in this setting in the past year. The FDA also approved Tecentriq (atezolizumab), which acts as a programmed cell death ligand–1 inhibitor, in May 2016.
The new approval was based on a study in 270 patients with locally advanced or metastatic urothelial carcinoma who experienced disease progression during or following platinum-containing chemotherapy, or whose disease progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
The objective response rate following Opdivo treatment was 19.6%; 7 patients had complete responses, and 46 had partial responses. The estimated median duration of response was 10.3 months. The FDA notes that some responses were ongoing at data cutoff.
For this Opdivo, application, the FDA granted a breakthrough therapy designation and priority review status. The application was approved about 1 month ahead of schedule.
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