title: Sunitinib as a paradigm for tyrosine kinase inhibitor development for renal cell carcinoma.
abstract: OBJECTIVE
  To describe the drug development and regulatory approval process for tyrosine kinase inhibitors in renal cell carcinoma using sunitinib as a model drug.
  
  
  METHODS
  Key findings from pivotal clinical trials that contributed to regulatory approval and drug development were reviewed.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  The 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.
authors.affiliation: Genito-urinary Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY.
authors.forename: Chung-Han
authors.initials: CH
authors.lastname: Lee
authors.affiliation: Genito-urinary Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY. Electronic address: motzerr@mskcc.org.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Motzer
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011758:Pyrroles / Q000627:therapeutic use*; D000077210:Sunitinib
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D047428:Protein Kinase Inhibitors; D011758:Pyrroles; D000077210:Sunitinib
keywords: Renal cell carcinoma; Sunitinib; Targeted agents