Drug updated on 10/25/2024
| 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.
Latest News
Summary
- This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
- Lenvatinib combined with pembrolizumab demonstrated numerical improvements in overall survival (OS) for intermediate-/poor-risk subgroups compared to tivozanib, although no statistically significant differences were determined due to within-trial proportional hazards violations.
- In second-line treatments for metastatic clear-cell renal cell carcinoma (ccRCC), tivozanib ranked sixth for progression-free survival (PFS (ORR)), overall survival (OS), and objective response rate (ORR), showing lower effectiveness compared to lenvatinib + everolimus, cabozantinib, and nivolumab.
- The combination of tivozanib with nivolumab showed an overall response rate (ORR) of 56%, indicating high efficacy in this context.
- Tivozanib had the highest P score for adverse events (AEs), grade ≥3 AEs, dose modifications due to AEs, and grade ≥3 diarrhea, indicating significant safety concerns compared to other TKIs.
- Tivozanib was noted as the riskiest agent for respiratory AEs and had significant risks for grade ≥3 AEs, contributing to its overall safety profile concerns.
- Tivozanib, when combined with nivolumab, was considered safe and effective in both PD-L1 positive and negative clear-cell renal cell carcinoma (ccRCC) patients.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Fotivda (tivozanib) Prescribing Information. | 2024 | AVEO Pharmaceuticals, Inc., Boston, MA |