FOTIVDA
PeakSMtivozanib
NDAORALCAPSULE
Approved
Mar 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
7/8 — Comprehensive
FOTIVDA (tivozanib) is inhibitor. Approved for renal cell carcinoma. First approved in 2021.
Drug data last refreshed 22h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FOTIVDA (tivozanib) is an oral tyrosine kinase inhibitor approved in March 2021 for treatment-refractory advanced renal cell carcinoma (RCC) in patients who have received two or more prior systemic therapies. The drug works by inhibiting vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, VEGFR-3) and other kinases including c-kit and PDGFR-β, thereby blocking angiogenesis and tumor growth. It represents a targeted therapy option for heavily pre-treated RCC patients in the late-line treatment setting.
$0.1BPart D
13.5 years to LOEMechanism of Action
inhibitor. In vitro cellular kinase assays demonstrated that tivozanib inhibits phosphorylation of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2 and VEGFR-3 and inhibits other kinases including c-kit and PDGFR β at clinically relevant concentrations. In tumor xenograft models in…
Indications (1)
Clinical Trials (7)
Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer
Started Mar 2025
1,040 enrolled
Clear Cell Renal Cell CarcinomaRenal Cell Carcinoma (RCC)Stage II Renal Pelvis Cancer AJCC v8+1 more
Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types
Started Dec 2021
29 enrolled
Bile Duct CancerGall Bladder CancerBreast Cancer+6 more
Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma
Started Sep 2021
343 enrolled
Renal Cell Carcinoma
A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
Started Sep 2019
27 enrolled
Hepatocellular Carcinoma
Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC
Started Mar 2017
28 enrolled
Carcinoma, Renal Cell
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.