Drug updated on 3/28/2024
| 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.
Summary
- 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.
- A systematic review and network meta-analysis found that tivozanib, when used as monotherapy, had a better safety profile compared to other tyrosine kinase inhibitors (TKIs). It achieved the highest P score for adverse events, grade ≥3 adverse events, dose modifications due to adverse events, and grade ≥3 diarrhea among all TKIs studied.
- In contrast to its favorable safety profile in monotherapy use, combinations of TKIs including tivozanib were shown to have poorer safety profiles than those used alone according to the same study.
- The European Medicines Agency approved Fotivda based on evidence from a single pivotal trial called TIVO-1 which presented critical limitations potentially rendering its results inconclusive; this was highlighted by another systematic review that also noted discrepancies between benefits observed for progression-free survival and absence of difference for overall survival in this trial.
- An updated Cochrane Review assessing targeted therapies for clear cell metastatic RCC included several comparative randomized controlled trials involving combinations of TKIs like tivozanib; it concluded that some combination treatments appear superior in terms of progression-free survival and overall survival with a favourable side effect profile compared to single-agent targeted therapy such as sunitinib but not necessarily tivozanib specifically.
- These findings are derived from three Systematic Reviews / Meta-Analyses documents focusing on the effectiveness and safety aspects related specifically towards Fotivda's indication - treating adults with relapsed or refractory advanced RCC after they've undergone at least two prior systemic therapies.
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 |
|---|---|---|
| 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 |
| Targeted therapy for metastatic renal cell carcinoma. | 2020 | Cochrane Database of Systematic Reviews |
| Tivozanib for treating advanced renal cell carcinoma. | 2018 | NICE |