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. 2022 Feb 1;28(3):441-445.
doi: 10.1158/1078-0432.CCR-21-2334. Epub 2021 Aug 20.

FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma

Elaine Chang  1 , Chana Weinstock  2 , Lijun Zhang  2 , Mallorie H Fiero  2 , Miao Zhao  2 , Eias Zahalka  2 , Tiffany K Ricks  2 , Jeanne Fourie Zirkelbach  2 , Junshan Qiu  2 , Jingyu Yu  2 , Xiao Hong Chen  2 , Vishal Bhatnagar  3 , Kirsten B Goldberg  3 , Shenghui Tang  2 , Paul G Kluetz  2   3 , Richard Pazdur  2   3 , Amna Ibrahim  2 , Julia A Beaver  2   3 , Laleh Amiri-Kordestani  2
Affiliations

FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma

Elaine Chang et al. Clin Cancer Res. .

Abstract

On March 10, 2021, the FDA granted regular approval to tivozanib for treatment of patients with relapsed or refractory (R/R) advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. Approval was based on the TIVO-3 study, a randomized trial of tivozanib versus sorafenib in patients with R/R advanced RCC. In TIVO-3, patients were randomized to receive either tivozanib 1.34 mg orally once daily for 21 consecutive days of every 28-day cycle or sorafenib 400 mg orally twice daily continuously. The primary endpoint was progression-free survival (PFS) per RECIST v1.1. Tivozanib demonstrated efficacy compared with sorafenib with an improvement in PFS [HR, 0.73; 95% confidence interval (CI), 0.56-0.95; P = 0.016]. The estimated median PFS was 5.6 months and 3.9 months in the tivozanib and sorafenib arms, respectively. There was no evidence of a detrimental effect on overall survival: HR, 0.97 (95% CI, 0.75-1.24). The most common grade 3 to 4 adverse reaction on the tivozanib arm was hypertension (24%). Compared with sorafenib, tivozanib was associated with lower rates of grade 3 to 4 diarrhea, rash, and palmar-plantar erythrodysesthesia. Patients receiving tivozanib in TIVO-3 had lower rates of dose reduction, interruption, or permanent discontinuation than those receiving sorafenib.

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Conflict of interest statement

Disclosure of Potential Conflicts of Interest: The authors report no financial interests or relationships with the commercial sponsors of any products discussed in this report.

Figures

Figure 1.
Figure 1.
Patient-Reported Outcomes from TIVO-1: Distribution of Responses to “I Am Bothered by Side Effects of Treatment” Notes: n = number of respondents to this question
See this image and copyright information in PMC

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