2021 Agustus: Tivozanib (Fotivda, AVEO Farmasi, Inc.), panghambat kinase, parantos disahkeun ku FDA pikeun penderita sawawa kalayan karamban sél ginjal maju (RCC) saatos dua atanapi langkung terapi sistemik.
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).
PFS median dina panangan tivozanib (n = 175) nyaéta 5.6 bulan (95 persén CI: 4.8, 7.3), dibandingkeun sareng 3.9 bulan (95 persén CI: 3.7, 5.6) dina panangan sorafenib (HR 0.73; 95 persén CI: 0.56, 0.95; p = 0.016). OS median pikeun kelompok tivozanib sareng sorafenib nyaéta 16.4 bulan (95 persén CI: 13.4, 21.9) sareng 19.2 bulan (95 persén CI: 14.9, 24.2), masing-masing (HR 0.97; 95 persén CI: 0.75, 1.24). ORR pikeun panangan tivozanib nyaéta 18 persén (95 persén CI: 12 persén, 24 persén) sareng pikeun panangan sorafenib 8 persén (95 persén CI: 4 persén, 13 persén).
Kacapean, hipertensi, diare, turun napsu, seueul, disphonia, hypothyroidism, batuk, sareng stomatitis mangrupikeun épék ngarugikeun anu paling sering (20%). Ngurangan natrium, ningkat lipase, sareng turun fosfat mangrupikeun tingkat paling umum tingkat 3 atanapi 4 abnormalitas laboratorium (5%).
Dosis tivozanib anu disarankeun nyaéta 1.34 mg sakali dinten (nganggo atanapi henteu nganggo tuang) salami 21 dinten, dituturkeun ku istirahat 28 dinten dugi ka perkembangan penyakit atanapi karacunan anu teu kaampeuh.
Rujukan: https://www.fda.gov/
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