# FOTIVDA® (tivozanib): Metastatic Renal Cell Carcinoma (mRCC) Treatment > 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. Official healthcare professional site providing clinical data, safety information, dosing guidelines, and patient support resources for FOTIVDA (tivozanib), a VEGFR tyrosine kinase inhibitor. **Key Clinical Data**: Median PFS 5.6 months vs 3.9 months with sorafenib (HR=0.73, 95% CI: 0.56-0.95, P=0.02) in TIVO-3 phase 3 study. Long-term PFS from 5-year follow-up. **NCCN Recommendation**: Tivozanib (FOTIVDA) is an NCCN recommended subsequent therapy for relapsed or stage IV ccRCC, after IO combination therapy. **Tolerability**: 80% of patients continued treatment without stopping due to adverse reactions; 76% maintained full dose without reductions due to adverse reactions. **Safety**: Common adverse reactions include hypertension (44%, 22% ≥Grade 3), fatigue/asthenia, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, stomatitis. Serious warnings include cardiac failure, cardiac ischemia, arterial/venous thromboembolism, hemorrhagic events, proteinuria, GI perforation, thyroid dysfunction, wound healing complications, RPLS, and embryo-fetal toxicity. **Abbreviations**: ccRCC=clear cell renal cell carcinoma, CI=confidence interval, HR=hazard ratio, ICI=immune checkpoint inhibitor, IO=immuno-oncology, mPFS=median progression-free survival, mRCC=metastatic renal cell carcinoma, NCCN=National Comprehensive Cancer Network, PPE=palmar-plantar erthrodysesthesia syndrome, PFS=progression-free survival, mPFS=median progression-free survival, RCC=renal cell carcinoma, rrRCC=relapsed/refractory renal cell carcinoma, TKI=tyrosine kinase inhibitor, VEGFR=vascular endothelial growth factor receptor, VTE=venous thrombotic events, RPLS=reversible posterior leukoencephalopathy syndrome. **Key Thought Leaders**: Chandler H. Park, MD, MSc, FACP, Co-Director of GU Clinical Trials at Norton Cancer Institue and Advisory Dean and Clinical Professor at Universeity of Louisville School of Medicine. Pedro C. Barata, MD, MSc, Director of GU Medical Oncology Research Program at University Hospitals Seidman Cancer Center and Associate Professor of Medicine at Case Western Reserve University. ## Mechanism of Action - [Mechanism of Action](https://www.fotivdahcp.com/mechanism-of-action/): FOTIVDA (tivozanib) is a potent and selective triple vascular endothelial growth factor receptor (VEGFR) inhibitor with a long half-life. Highly vascular tumors in clear cell rrRCC demand VEGFR inhibition. Less selective VEGFR TKIs inhibit a range of other kinases. ## Efficacy - [Efficacy Overview](https://www.fotivdahcp.com/efficacy/): Treatment scenarios include FOTIVDA (tivozanib) as a second-line treatment option for metastatic renal cell carcinoma (mRCC), following ICI-based combination therapy. - [Study Design](https://www.fotivdahcp.com/efficacy/study-design/): Overview of TIVO-3 study design and patient population, a phase 3, randomized, controlled, open-label clinical trial. TIVO-3 is the first and only prospective, Phase 3 study of a VEGFR TKI in rrRCC after 2 or more systemic therapies including IO. - [PFS Primary Endpoint](https://www.fotivdahcp.com/efficacy/pfs/): 44% improvement in median progression-free survival (PFS) data showing 5.6 vs 3.9 months (HR=0.73, 95% CI: 0.56-0.95, P=0.02). 28% of patients were progression free at 1 year versus 11% with sorafenib and 18% of patients were progression free at 2 years versus 5% with sorafenib. Long-term PFS from a 5-year follow up study shows PFS rates are consistently higher with FOTIVDA (tivozanib) versus sorafenib, with 12% versus 2% and 8% versus 0% at 3 and 4 years, respectively. - [PFS Subgroup Analysis](https://www.fotivdahcp.com/efficacy/pfs-subgroup-analysis/): PFS subgroup survival analysis demonstrates efficacy across patient subgroups including prior therapy types including prior checkpoint inhibitor and prior VEGFR TKI and two prior VEGFR TKIs. - [Response Rates](https://www.fotivdahcp.com/efficacy/response/): Objective response rates and duration of response data. FOTIVDA (tivozanib) showed clinically meaningful response after 2 or more prior systemic therapies in metastatic renal cell carcinoma (mRCC). 71% of responders were still responding to FOTIVDA (tivozanib) at 12 months. ## Safety and Tolerability - [Adverse Reactions Profile](https://www.fotivdahcp.com/tolerability-safety/adverse-reactions/): Complete adverse reactions data from TIVO-3 including frequency and grade - [Tolerability Analysis](https://www.fotivdahcp.com/tolerability-safety/tolerability/): Treatment duration, discontinuation rates, and dose modification data. 80% of patients were able to stay on FOTIVDA (tivozanib) without stopping due to side effects, and 76% were able to take full dose without reducing due to side effects. ## Dosing and Administration - [Dosing Guidelines](https://www.fotivdahcp.com/dosing/): Recommended dose of 1.34 mg orally once daily on 21-day on/7-day off schedule - [Dose Modifications](https://www.fotivdahcp.com/dosing/dose-modifications/): Guidelines for dose reductions and interruptions based on adverse reactions - [Dosing Guide](https://www.fotivdahcp.com/wp-content/uploads/2024/10/FOTIVDA-Dosing-Guide-4.pdf): Downloadable dosing guide ## Patient Access and Support - [Access and Support Overview](https://www.fotivdahcp.com/access-support/): Overview of patient support programs and resources - [Distribution Information](https://www.fotivdahcp.com/access-support/distribution/): How to obtain FOTIVDA (tivozanib) through specialty pharmacies and distributors - [AVEO ACE Patient Support](https://www.fotivdahcp.com/access-support/aveo-ace/): Comprehensive support program providing personalized support, financial assistance and educational resources ## HCP Resources - [Downloadable Resources](https://www.fotivdahcp.com/resources/): HCP and access resources, patient brochures, dosing guide, and other educational materials - [Video Resources](https://www.fotivdahcp.com/resources/videos/): Expert discussions and clinical perspectives on FOTIVDA use ## Essential Documents - [Full Prescribing Information](https://www.fotivdahcp.com/fotivdapi.pdf): Complete USPI including indication, dosing, warnings, and adverse reactions - [Request Account Manager](https://www.fotivdahcp.com/request-a-rep/): Connect with a FOTIVDA representative - [Patient Website](http://fotivda.com/): Educational resources and support information for patients and caregivers --- *For US Healthcare Professionals Only | Contact: 1-833-FOTIVDA (1-833-368-4832) | AVEO Pharmaceuticals, Inc. | US-MAT-00001 01/26*