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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Vydáno v:Oncologist
Hlavní autoři: Xu, James Xunhai, Maher, V. Ellen, Zhang, Lijun, Tang, Shenghui, Sridhara, Rajeshwari, Ibrahim, Amna, Kim, Geoffrey, Pazdur, Richard
Médium: Artigo
Jazyk:Inglês
Vydáno: AlphaMed Press 2017
Témata:
Regulatory Issues: FDA
On-line přístup: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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