Sunitinib as a paradigm for tyrosine kinase inhibitor development for renal cell carcinoma Journal Article
| Authors: | Lee, C. H.; Motzer, R. J. |
| Article Title: | Sunitinib as a paradigm for tyrosine kinase inhibitor development for renal cell carcinoma |
| Abstract: | Objectives: To describe the drug development and regulatory approval process for tyrosine kinase inhibitors in renal cell carcinoma using sunitinib as a model drug. Methods and materials: 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. © 2015 Elsevier Inc. |
| Keywords: | cancer chemotherapy; cancer survival; review; sunitinib; drug approval; cancer patient; food and drug administration; drug development; renal cell carcinoma; kidney carcinoma; standardization; targeted agents; randomized controlled trial (topic); phase 2 clinical trial (topic); phase 3 clinical trial (topic); phase 1 clinical trial (topic); human; priority journal |
| Journal Title: | Urologic Oncology: Seminars and Original Investigations |
| Volume: | 33 |
| Issue: | 6 |
| ISSN: | 1078-1439 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2015-06-01 |
| Start Page: | 275 |
| End Page: | 279 |
| Language: | English |
| DOI: | 10.1016/j.urolonc.2014.10.012 |
| PROVIDER: | scopus |
| PUBMED: | 25465298 |
| DOI/URL: | |
| Notes: | Export Date: 2 July 2015 -- Source: Scopus |
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