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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Bibliographische Detailangaben
Veröffentlicht in:Oncologist
Hauptverfasser: Xu, James Xunhai, Maher, V. Ellen, Zhang, Lijun, Tang, Shenghui, Sridhara, Rajeshwari, Ibrahim, Amna, Kim, Geoffrey, Pazdur, Richard
Format: Artigo
Sprache:Inglês
Veröffentlicht: AlphaMed Press 2017
Schlagworte:
Regulatory Issues: FDA
Online Zugang: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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