Drug updated on 9/4/2024
| Dosage Form | Capsule (oral; 1.34 mg, 0.89 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
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Summary
- Fotivda (tivozanib) is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
- This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
- Overall Response Rates (ORR): The highest ORR was observed with Pembrolizumab + Tyrosine Kinase Inhibitor (59.3-73%), followed by Nivolumab + Tivozanib (56%) and Avelumab + Axitinib (51.5-58%). In contrast, Everolimus demonstrated the lowest ORR at 5%.
- Progression-Free Survival (PFS): Cabozantinib showed a strong PFS benefit with an HR of 0.26 (95% CrI 0.14-0.44). Sunitinib was less favorable in PFS when compared to combination therapies, with an HR of 1.45 (95% CI ranging from 1.17 to 1.80).
- Overall Survival (OS): Pembrolizumab + Axitinib significantly improved OS with an HR of 0.41 (95% CrI 0.16-0.85) compared to Sunitinib, which had an HR of 1.90 (95% CI 1.36-2.65).
- Tivozanib demonstrated the highest P score for adverse events (AEs), including grade ≥3 AEs, dose modifications due to AEs, and grade ≥3 diarrhea, indicating a significant safety concern compared to other therapies.
- Combination therapies, including Lenvatinib + Pembrolizumab, were associated with a worse safety profile, particularly with a high incidence of grade ≥3 AEs, compared to monotherapies like Sorafenib and Tivozanib.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Fotivda (tivozanib) Prescribing Information. | 2021 | AVEO Pharmaceuticals, Inc. Boston, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of checkpoint inhibitors in clear cell renal cell carcinoma: A systematic review of clinical trials. | 2023 | Hematology/Oncology and Stem Cell Therapy |
| Comparative safety of tyrosine kinase inhibitors in the treatment of metastatic renal cell carcinoma: a systematic review and network meta-analysis. | 2023 | Frontiers in Pharmacology |
| Tivozanib in renal cell carcinoma: a systematic review of the evidence and its dissemination in the scientific literature. | 2022 | BMC Cancer |
| Optimizing targeted drug selection in combination therapy for patients with advanced or metastatic renal cell carcinoma: a systematic review and network meta-analysis of safety. | 2022 | Cancer Medicine |
| A network meta-analysis of efficacy and safety of first-line and second-line therapies for the management of metastatic renal cell carcinoma. | 2021 | Journal of Clinical Pharmacy and Therapeutics |
| Targeted therapy for metastatic renal cell carcinoma. | 2020 | Cochrane Database of Systematic Reviews |