Urology FDA approvals of 2016
FDA approves RCC treatment that targets immune system
Bristol-Myers Squibb received FDA approval for nivolumab (Opdivo) injection, for intravenous use, for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that works by targeting the immune system through the PD-1 immune checkpoint pathway. It is the first PD-1 inhibitor to deliver significant overall survival in patients with advanced RCC who have received prior anti-angiogenic therapy, according to Bristol-Myers Squibb. The approval was based on data from a study of patients with advanced RCC who were randomized to receive either nivolumab or everolimus (Afinitor). Those treated with nivolumab lived an average of 25 months after treatment initiation versus 19.6 months in those treated with everolimus. The most common side effects associated with the use of nivolumab include weakness and lack of energy, cough, nausea, rash, dyspnea, and arthralgia.
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