Introduction

Tivozanib (trade name: Fotivda) has been approved in Germany since August 2017 for the treatment of advanced renal cell cancer in adults.

Renal cell cancer is the most common type of kidney cancer. It usually goes unnoticed for a long time as symptoms only occur in people with advanced, larger tumors. Symptoms include pain in the kidney area that may radiate into the back, as well as blood in urine. If renal cell cancer has already grown too much or spread to other organs, surgery to remove it may no longer be an effective treatment.

Some people with advanced renal cell cancer have a mutated (changed) protein in their tumor tissue called a vascular endothelial growth factor (VEGF). This mutated protein may contribute to uncontrolled growth of the tumor. The protein mTOR (mechanistic target of rapamycin) can also increase tumor growth.

Tivozanib is used in patients with advanced renal cell cancer who have not had treatment before. It is also an option for patients whose disease advances despite cytokine therapy and who have not had treatment with drugs that act against VEGF and mTOR.

Tivozanib aims to block VEGF in the tumor tissue and inhibit tumor growth.

Application

Tivozanib is taken once a day in the form of a hard capsule containing 1.34 µg of the drug.

Tivozanib is used in treatment cycles of four weeks each. For the first 21 days tivozanib is taken daily. No tablets are taken on the final seven days of the cycle. After a total of 28 days, the next cycle begins.

Other treatments

Drugs such as pazopanib and sunitinib are used in the first-line treatment of advanced renal cell cancer

For patients whose disease progresses despite cytokine therapy and who have not had treatment with drugs that act against VEGF and mTOR before, the drugs axitinib or sorafenib are options.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to find out whether tivozanib has any advantages or disadvantages for people with advanced renal cell cancer when compared with the current standard treatments.

But the manufacturer didn't provide any suitable data with which to answer this question: neither for patients who are having treatment for the first time, nor for patients whose disease progresses despite cytokine therapy and who have not yet had treatment with drugs that act against VEGF and mTOR.

More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of tivozanib (Fotivda).