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Sunitinib as a paradigm for tyrosine kinase inhibitor development for renal cell carcinoma
Chung-Han Lee1, Robert J Motzer1
1Genito-urinary Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY.
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.
Insights
Sunitinib
Area of Science:
- Oncology
- Pharmacology
- Drug Development
Background:
- Renal cell carcinoma (RCC) is a complex malignancy.
- Tyrosine kinase inhibitors (TKIs) have emerged as a critical treatment modality for RCC.
Purpose of the Study:
- To elucidate the drug development and regulatory approval pathway for TKIs in RCC.
- To utilize sunitinib as a model drug to illustrate this process.
Main Methods:
- Review of pivotal clinical trial findings that supported regulatory approval.
- Analysis of the sequential development stages from preclinical research to post-approval studies.
Main Results:
- Sunitinib's development involved preclinical studies, Phase I, II, and III clinical trials.
- It received accelerated and standard approval from the Food and Drug Administration (FDA).
- Sunitinib is now a first-line RCC therapy and a benchmark for new drug development.
Conclusions:
- Sunitinib's journey exemplifies successful "bench to bedside" translation in RCC.
- This model can guide the development of future targeted therapies for renal cell carcinoma.
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