In this article
FDA Approval of Tivozanib for Relapsed/Refractory RCC
August 2021: Tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), a kinase inhibitor, has been approved by the FDA for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) after two or more prior systemic therapy.
TIVO-3 (NCT02627963), a randomised (1:1), open-label, multicenter trial of tivozanib versus sorafenib in patients with relapsed or refractory advanced RCC who had received two or three prior systemic treatments, including at least one VEGFR kinase inhibitor other than sorafenib or tivozanib, was used to assess efficacy. Patients were given either tivozanib 1.34 mg orally once daily for 21 consecutive days every 28 days or sorafenib 400 mg orally twice a day until disease progression or intolerable toxicity, whichever came first.
TIVO-3 Trial Results: PFS and Overall Survival
Progression-free survival (PFS) was the primary efficacy outcome measure, which was reviewed by a blinded independent radiological review committee. Overall survival (OS) and objective response rate were two other effectiveness objectives (ORR).
The median PFS in the tivozanib arm (n=175) was 5.6 months (95 percent CI: 4.8, 7.3), compared to 3.9 months (95 percent CI: 3.7, 5.6) in the sorafenib arm (HR 0.73; 95 percent CI: 0.56, 0.95; p=0.016). The median OS for the tivozanib and sorafenib groups was 16.4 months (95 percent CI: 13.4, 21.9) and 19.2 months (95 percent CI: 14.9, 24.2), respectively (HR 0.97; 95 percent CI: 0.75, 1.24). The ORR for the tivozanib arm was 18 percent (95 percent CI: 12 percent, 24 percent) and for the sorafenib arm was 8 percent (95 percent CI: 4 percent, 13 percent).
Side Effects and Recommended Dosage
Fatigue, hypertension, diarrhoea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis were the most prevalent (20%) adverse effects. Decreased sodium, increased lipase, and decreased phosphate were the most prevalent grade 3 or 4 laboratory abnormalities (5%).
The recommended tivozanib dose is 1.34 mg once day (with or without meals) for 21 days, followed by a 28-day break until disease progression or intolerable toxicity.
Reference :
Check details .
How CancerFax Helps
CancerFax is a specialist cancer access and patient-navigation platform. We help patients and families understand their options, organise medical records, coordinate hospital communication, and support cross-border treatment planning where appropriate.
We help collect and organise reports, scans, pathology, biomarker results, and treatment history for structured case review.
We communicate with hospitals or trial teams to assess whether a case may be suitable for further screening.
We support appointment coordination, document submission, translation, and direct communication with international departments.
For international patients, we help with practical coordination — travel planning, hospital admission guidance, and local support.
If this option is not suitable, we help explore other relevant treatments, clinical trials, or advanced care pathways.
From inquiry through to follow-up, our coordinators provide a single point of contact for the family.
CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
About Susan Hau
Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy. Hau's expertise lies in cancer cell biolo…
✓ Reviewed for medical accuracy by the CancerFax review panel.
Medical Disclaimer
This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
Treatment availability, eligibility, timelines, and access can change. Any clinical trial participation depends on detailed review and approval by the trial hospital or investigator.