کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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3999488 | 1259340 | 2015 | 5 صفحه PDF | دانلود رایگان |
ObjectivesTo describe the drug development and regulatory approval process for tyrosine kinase inhibitors in renal cell carcinoma using sunitinib as a model drug.Methods and materialsKey findings from pivotal clinical trials that contributed to regulatory approval and drug development were reviewed.ResultsThe pathway of development for sunitinib starts from preclinical models to a phase I clinical trial followed by 2 phase II clinical trials for Food and Drug Administration accelerated approval and a phase III clinical trial for Food and Drug Administration standard approval. After standard approval, optimal dosing and use in the adjuvant setting were further explored. As an established first-line therapy for renal cell carcinoma, sunitinib is now used as a comparator arm for other drugs.ConclusionsThe development of sunitinib is a model example of “bench to bedside” work in renal cell carcinoma and may provide a framework for the development of other drugs.
Journal: Urologic Oncology: Seminars and Original Investigations - Volume 33, Issue 6, June 2015, Pages 275–279