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Updated: Feb 9, 2026
Modeling Spontaneous Metastatic Renal Cell Carcinoma mRCC in Mice Following Nephrectomy
Published on: April 29, 2014
Tivozanib for the treatment of renal cell carcinoma
Matteo Santoni1, Francesco Massari2, Francesco Piva3
1a Oncology Unit , Macerata Hospital , Macerata , Italy.
Introduction:
Renal cell carcinoma (RCC) represents a heterogeneous group of cancers with distinct histological features, molecular alterations, prognosis, and response to therapy. Target agents directed against vascular endothelial growth factor and its receptor and mammalian target of rapamycin (mTOR) inhibitors have completely changed the landscape of RCC. However, the rate of complete response is still low, thus supporting the research of novel therapeutic agents. Area covered: The authors describe the chemical features of tivozanib, its pharmacodynamic and pharmacokinetic properties, and the results obtained in human phase I-III clinical trials. Tivozanib received its first global approval in EU, Iceland, and Norway on 28 August 2017 for the first-line treatment of adult patients with advanced RCC and for adult patients who are VEGFR and mTOR inhibitor-naive following disease progression after one prior treatment with cytokines. Expert opinion: The US Food and Drug Administration did not approve tivozanib due to the lack of a significant advantage in terms of survival compared to sorafenib. To date, the role of tivozanib in the pharmaceutical landscape of mRCC appears to be very limited. However, ongoing trials on the association between tivozanib and immunotherapy may represent a promising strategy to be assessed in future clinical trials.
Insights
Tivozanib, a vascular endothelial growth factor inhibitor, shows limited benefit in advanced renal cell carcinoma (RCC) compared to sorafenib. Ongoing trials exploring tivozanib with immunotherapy may offer future promise for metastatic RCC (mRCC) treatment.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Renal cell carcinoma (RCC) is a complex cancer with evolving treatment paradigms.
- Vascular endothelial growth factor (VEGF) and mammalian target of rapamycin (mTOR) inhibitors have advanced RCC therapy.
- Despite progress, low complete response rates necessitate novel therapeutic agents.
Purpose of the Study:
- To review the chemical properties, pharmacodynamics, and pharmacokinetics of tivozanib.
- To analyze clinical trial outcomes for tivozanib in advanced renal cell carcinoma.
- To assess the current and potential future role of tivozanib in mRCC treatment.
Main Methods:
- Review of tivozanib's chemical and biological characteristics.
- Analysis of Phase I-III clinical trial data for tivozanib in advanced RCC.
- Evaluation of regulatory approvals and expert opinions on tivozanib efficacy.
Main Results:
- Tivozanib received EU approval for advanced RCC in specific patient populations.
- The US FDA did not approve tivozanib due to insufficient survival advantage over sorafenib.
- Tivozanib's current role in metastatic RCC (mRCC) appears limited.
Conclusions:
- Tivozanib demonstrates specific therapeutic applications in advanced RCC based on EU approval.
- Comparative efficacy against sorafenib remains a key limitation for broader FDA approval.
- Combination therapy with immunotherapy presents a potential future avenue for tivozanib in mRCC.
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