Fotivda® (tivozanib) is now available for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) after 2 or more prior systemic therapies.

Fotivda, an oral vascular endothelial growth factor tyrosine kinase inhibitor, was approved based on data from the phase 3 TIVO-3 trial [ NCT02627963], which showed significantly longer progression free survival (primary endpoint) among patients treated with tivozanib compared with sorafenib.

As for safety, the most common adverse reactions with Fotivda include fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis. The most common grade 3 or 4 laboratory abnormalities are decreased sodium, increased lipase, and decreased phosphate. Additional significant adverse reactions that have been observed include hypertensive crisis, cardiac failure, cardiac ischemia and arterial thromboembolic events, venous thromboembolic events, hemorrhagic events, proteinuria, and thyroid dysfunction. Impaired wound healing and reversible posterior leukoencephalopathy syndrome may also be associated with Fotivda treatment.

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Fotivda is supplied as 0.89mg and 1.34mg capsules in 21-count bottles. The 0.89mg capsules contain tartrazine, which may cause allergic-type reactions in certain patients.

To assist with access, affordability and treatment adherence, AVEO Oncology has initiated the AVEO ACE Patient Support program. “We are thrilled to begin bringing Fotivda to patients battling relapsed or refractory kidney cancer,” said Michael Bailey, president and chief executive officer of AVEO. “With its differentiated tolerability and efficacy profile, Fotivda has the potential to serve as a meaningful, evidence-based treatment option for the population of patients who have previously received 2 prior lines of systemic therapy.”


  1. AVEO Oncology announces U.S. commercial availability of Fotivda® (tivozanib) for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma ahead of previous guidance. [press release]. Boston, MA: Aveo Oncoloy; March 22, 2021.
  2. Fotivda® [prescribing information]. Boston, MA; AVEO Pharmaceuticals. 2021.

This article originally appeared on MPR