Augustus 2021: Tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), a kinase inhibitor, has been approved by the FDA for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) after two or more prior systemic therapy.
TIVO-3 (NCT02627963), a randomised (1:1), open-label, multicenter trial of tivozanib versus sorafenib in patients with relapsed or refractory advanced RCC who had received two or three prior systemic treatments, including at least one VEGFR kinase inhibitor other than sorafenib or tivozanib, was used to assess efficacy. Patients were given either tivozanib 1.34 mg orally once daily for 21 consecutive days every 28 days or sorafenib 400 mg orally twice a day until disease progression or intolerable toxicity, whichever came first.
Progression-free survival (PFS) was the primary efficacy outcome measure, which was reviewed by a blinded independent radiological review committee. Overall survival (OS) and objective response rate were two other effectiveness objectives (ORR).
The median PFS in the tivozanib arm (n=175) was 5.6 months (95 percent CI: 4.8, 7.3), compared to 3.9 months (95 percent CI: 3.7, 5.6) in the sorafenib arm (HR 0.73; 95 percent CI: 0.56, 0.95; p=0.016). The median OS for the tivozanib and sorafenib groups was 16.4 months (95 percent CI: 13.4, 21.9) and 19.2 months (95 percent CI: 14.9, 24.2), respectively (HR 0.97; 95 percent CI: 0.75, 1.24). The ORR for the tivozanib arm was 18 percent (95 percent CI: 12 percent, 24 percent) and for the sorafenib arm was 8 percent (95 percent CI: 4 percent, 13 percent).
Fatigue, hypertension, diarrhoea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis were the most prevalent (20%) adverse effects. Decreased sodium, increased lipase, and decreased phosphate were the most prevalent grade 3 or 4 laboratory abnormalities (5%).
The recommended tivozanib dose is 1.34 mg once day (with or without meals) for 21 days, followed by a 28-day break until disease progression or intolerable toxicity.
Verwysing: https://www.fda.gov/
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