As per the notification on 10 March 2021, tivozanib received Food and Drug Administration (FDA) approval for the treatment of adult patients suffering from relapsed or refractory advanced renal cell carcinoma.
This randomized, multicenter, open-label trial of tivozanib versus sorafenib (TIVO-3) investigated the efficacy of tivozanib (a kinase inhibitor) in individuals having advanced kidney cancer, following two or more prior systemic therapies, including at least one vascular endothelial growth factor receptor (VEGFR) kinase inhibitor other than sorafenib or tivozanib.
The study population was randomly divided into two arms: (i) Tivozanib 1.34 mg orally once daily for 21 consecutive days every 28 days, or (ii) Sorafenib 400 mg orally twice a day continuously until disease advancement or unacceptable toxicity.
The major outcome was
- Progression-free survival
Other efficacy outcomes were
- Objective response rate
- Overall survival
The below table depicts the objective response rate, median progression-free survival, and median overall survival for the tivozanib and sorafenib group:
|Tivozanib group||Sorafenib group|
|Median progression-free survival||5.6 months||3.9 months|
|Median overall survival||16.4 months||19.2 months|
|Objective response rate||18%||8%|
Stomatitis, fatigue, decreased appetite, hypertension, diarrhea, nausea, cough, dysphonia, and hypothyroidism were the most commonly (≥20%) reported side effects. A rise in lipase and a decline in sodium and phosphate were the most common grade III or IV lab abnormalities (≥5%). For tivozanib, the suggested dose is 1.34 mg once daily (with or without food) for about 21 consecutive days every 28 days until unacceptable toxicity or advancement of the disease.
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|Original title of the article||FDA approves tivozanib for relapsed or refractory advanced renal cell carcinoma|