FDA Approves Tivozanib for Treatment of Relapsed or Refractory Advanced Renal Cell Carcinoma


The oral, next-generation vascular endothelial growth factor tyrosine kinase inhibitor is the first therapy approved for this patient population following 2 or more prior systemic therapies.

Officials with the FDA have approved tivozanib (Fotivda, AVEO Oncology) as the first therapy for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following 2 or more prior systemic therapies.

Tivozanib is an oral, next-generation vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). According to a press release, the company plans to make it available to patients in the United States by the end of March.

“Today’s approval of Fotivda provides a new tool for treating patients with kidney cancer who have relapsed or become refractory to 2 or more prior systemic therapies,” said Brian Rini, MD, chief of clinical trials at Vanderbilt ingram Cancer Center and principal investigator of the TIVO-3 trial, in the press release. “With advances in RCC treatment, patients are living longer, increasing the need for proven, well tolerated treatment options in the relapsed or refractory setting.”

The approval is based on the TIVO-3 study, which compared tivozanib to sorafenib in relapsed or refractory advanced RCC following 2 or more prior systemic therapies. The approval is also supported by 3 additional trials in RCC and includes safety data from more than 1000 clinical trial subjects, according to the press release.

Study participants were randomized 1:1 to receive either tivozanib or sorafenib. The main efficacy outcome measure was progression-free survival (PFS) and other efficacy endpoints were overall survival (OS) and objective response rate (ORR).

According to the press release, the median PFS was 5.6 months in the tivozanib arm compared to 3.9 months in the sorafenib arm. Median OS was 16.4 and 19.2 months for the tivozanib and sorafenib arms, respectively, whereas the ORR was 18% for those receiving tivozanib and 8% for those receiving sorafenib.

“The TIVO-3 study is the first positive phase 3 study in RCC patients who received 2 or more prior systemic therapies, and also the first phase 3 RCC study to include a predefined population of patients who have received prior immunotherapy, the current standard of care in earlier-line treatment,” Rini said in the press release. “With this approval, I believe Fotivda represents an attractive intervention, and expect it to play a meaningful role in the evolving RCC treatment landscape.”

The most common adverse events were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis. The most common grade 3 or 4 laboratory abnormalities were decreased sodium, increased lipase, and decreased phosphate. According to the press release, the recommended dose of 1.34 mg once daily with or without food for 21 days, on a 28-day cycle until disease progression or unacceptable toxicity.

“Relapsed or refractory RCC is a devastating disease for which patient outcomes can be limited due to the tradeoff between tolerability and efficacy,” said Dena Battle, president of KCCure, in the press release. “The FDA approval of Fotivda represents an exciting, meaningful advancement by providing a new treatment option for this patient population.”


AVEO Oncology Announces US FDA Approval of Fotivda (tivozanib) for the Treatment of Adult Patients with Relapsed or Refractory Advanced Renal Cell Carcinoma [news release]. AVEO Oncology; March 10, 2021. https://www.aveooncology.com/media/press-releases/. Accessed March 11, 2021.

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