Tivozanib (Fotivda)

Mechanism of action

From the NCI Drug Dictionary: An orally bioavailable inhibitor of vascular endothelial growth factor receptors (VEGFRs) 1, 2 and 3 with potential antiangiogenic and antineoplastic activities. Tivozanib binds to and inhibits VEGFRs 1, 2 and 3, which may result in the inhibition of endothelial cell migration and proliferation, inhibition of tumor angiogenesis and tumor cell death.

Diseases for which it is established

• Renal cell carcinoma
  • Clear cell renal cell carcinoma

Patient drug information

• Tivozanib (Fotivda) package insert
• Tivozanib (Fotivda) patient drug information (UpToDate)

History of changes in FDA indication

• 2021-03-10: Approved for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. (Based on TIVO-3)

History of changes in EMA indication

• 2017-08-24: Initial authorization for first line treatment of adult patients with advanced renal cell carcinoma (RCC). (Based on TIVO-1)
• 2017-08-24: Initial authorization for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC. (Based on TIVO-1)

Also known as

• Code name: AV-951
• Brand name: Fotivda