Summary

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• Tivozanib (Fotivda) is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
• Six studies were reviewed to gather information about this drug.
• The studies highlight that tivozanib, when combined with nivolumab, achieves an Overall Response Rate (ORR) of 56%, comparable to other combinations such as nivolumab + ipilimumab and nivolumab + cabozantinib.
• Among TKIs reviewed for monotherapy in RCC, tivozanib and sorafenib emerged as the best options in terms of balancing efficacy with safety. However, conflicting regulatory decisions introduce notable caution in interpreting these results outright.
• In terms of safety comparison, TKIs as monotherapies showed a better general safety profile compared to combination therapies with immunological agents. Specifically, tivozanib scored high for having fewer grade ≥3 Adverse Events and dose modifications due to AEs, indicating potential better tolerability.
• The studies underscored the effectiveness and safety of tivozanib across different populations including PD-L1 positive and negative ccRCC, but detailed subgroup analyses were less explicitly provided for Fotivda compared to other treatments, representing an area requiring further research.