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...

Πλήρης περιγραφή

Αποθηκεύτηκε σε:
Λεπτομέρειες βιβλιογραφικής εγγραφής
Τόπος έκδοσης:Oncologist
Κύριοι συγγραφείς: Xu, James Xunhai, Maher, V. Ellen, Zhang, Lijun, Tang, Shenghui, Sridhara, Rajeshwari, Ibrahim, Amna, Kim, Geoffrey, Pazdur, Richard
Μορφή: Artigo
Γλώσσα:Inglês
Έκδοση: AlphaMed Press 2017
Θέματα:
Regulatory Issues: FDA
Διαθέσιμο Online: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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