FDA Approval Summary: Nivolumab in Advanced Renal Cell Carcinoma After Anti‐Angiogenic Therapy and Exploratory Predictive Biomarker Analysis

On November 23, 2015, the U.S. Food and Drug Administration approved nivolumab (OPDIVO, Bristol‐Myers Squibb Company) for patients with advanced renal cell carcinoma (RCC) who have received prior anti‐angiogenic therapy. The approval was based on efficacy and safety data demonstrated in an open‐labe...

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Bibliographic Details
Published in:Oncologist
Main Authors: Xu, James Xunhai, Maher, V. Ellen, Zhang, Lijun, Tang, Shenghui, Sridhara, Rajeshwari, Ibrahim, Amna, Kim, Geoffrey, Pazdur, Richard
Format: Artigo
Language:Inglês
Published: AlphaMed Press 2017
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Regulatory Issues: FDA
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC5344649/
https://ncbi.nlm.nih.gov/pubmed/28232599
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2016-0476
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