August 2021: Tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), en kinasehæmmer, er blevet godkendt af FDA til voksne patienter med recidiverende eller refraktært fremskreden nyrecellekarcinom (RCC) efter to eller flere tidligere systemisk behandling.
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).
Median PFS i tivozanib-armen (n=175) var 5.6 måneder (95 procent CI: 4.8, 7.3), sammenlignet med 3.9 måneder (95 procent CI: 3.7, 5.6) i sorafenib-armen (HR 0.73; 95 procent CI: 0.56, 0.95; p=0.016). Median OS for tivozanib- og sorafenib-grupperne var henholdsvis 16.4 måneder (95 procent CI: 13.4, 21.9) og 19.2 måneder (95 procent CI: 14.9, 24.2) (HR 0.97; 95 procent CI: 0.75, 1.24). ORR for tivozanib-armen var 18 procent (95 procent CI: 12 procent, 24 procent) og for sorafenib-armen var 8 procent (95 procent CI: 4 procent, 13 procent).
Træthed, hypertension, diarré, nedsat appetit, kvalme, dysfoni, hypothyroidisme, hoste og stomatitis var de mest udbredte (20 %) bivirkninger. Nedsat natrium, øget lipase og nedsat fosfat var de mest udbredte grad 3 eller 4 laboratorieabnormiteter (5%).
Den anbefalede dosis tivozanib er 1.34 mg én gang dagligt (med eller uden måltider) i 21 dage, efterfulgt af en 28-dages pause indtil sygdomsprogression eller utålelig toksicitet.
Reference: https://www.fda.gov/
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