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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Detalles Bibliográficos
Autores principales: Xu, James Xunhai, Maher, V. Ellen, Zhang, Lijun, Tang, Shenghui, Sridhara, Rajeshwari, Ibrahim, Amna, Kim, Geoffrey, Pazdur, Richard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: AlphaMed Press 2017
Materias:
Regulatory Issues: FDA
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5344649/
https://www.ncbi.nlm.nih.gov/pubmed/28232599
http://dx.doi.org/10.1634/theoncologist.2016-0476

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5344649/
https://www.ncbi.nlm.nih.gov/pubmed/28232599
http://dx.doi.org/10.1634/theoncologist.2016-0476

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