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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Bibliografische gegevens
Gepubliceerd in:Oncologist
Hoofdauteurs: Xu, James Xunhai, Maher, V. Ellen, Zhang, Lijun, Tang, Shenghui, Sridhara, Rajeshwari, Ibrahim, Amna, Kim, Geoffrey, Pazdur, Richard
Formaat: Artigo
Taal:Inglês
Gepubliceerd in: AlphaMed Press 2017
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Regulatory Issues: FDA
Online toegang: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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