FDA Approval Summary: Temsirolimus as Treatment for Advanced Renal Cell Carcinoma

This report summarizes the U.S. Food and Drug Administration (FDA)'s approval of temsirolimus (Torisel®), on May 30, 2007, for the treatment of advanced renal cell carcinoma (RCC). Information provided includes regulatory history, study design, study results, and literature review. A multicente...

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Bibliografski detalji
Glavni autori: Kwitkowski, Virginia E., Prowell, Tatiana M., Ibrahim, Amna, Farrell, Ann T., Justice, Robert, Mitchell, Shan Sun, Sridhara, Rajeshwari, Pazdur, Richard
Format: Artigo
Jezik:Inglês
Izdano: AlphaMed Press 2010
Teme:
Regulatory Issues: FDA
Online pristup:https://ncbi.nlm.nih.gov/pmc/articles/PMC3227966/
https://ncbi.nlm.nih.gov/pubmed/20332142
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2009-0178
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