Agusta 2021: Tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), wani kinase hanawa, an amince da FDA domin adult marasa lafiya da relapsed ko tsaurin m koda cell sankara (RCC) bayan biyu ko fiye kafin tsari far.
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).
Matsakaicin PFS a cikin tivozanib hannu (n = 175) shine watanni 5.6 (95 bisa dari CI: 4.8, 7.3), idan aka kwatanta da watanni 3.9 (95 bisa dari CI: 3.7, 5.6) a cikin sorafenib hannu (HR 0.73; 95 bisa dari CI: 0.56, 0.95; p = 0.016). Matsakaicin OS don ƙungiyoyin tivozanib da sorafenib shine watanni 16.4 (95 bisa dari CI: 13.4, 21.9) da watanni 19.2 (95 bisa dari CI: 14.9, 24.2), bi da bi (HR 0.97; 95 kashi CI: 0.75, 1.24). ORR na hannun tivozanib ya kasance kashi 18 (95 bisa dari CI: kashi 12, kashi 24) kuma ga sorafenib hannu shine kashi 8 (95 bisa dari CI: kashi 4, kashi 13).
Gajiya, hauhawar jini, zawo, raguwar ci, tashin zuciya, dysphonia, hypothyroidism, tari, da stomatitis sune mafi yawan cutarwa (20%). Rage sodium, ƙara lipase, da rage phosphate sune mafi yawan abubuwan da aka saba da su na 3 ko 4 na rashin lafiya (5%).
Shawarar tivozanib da aka ba da shawarar ita ce 1.34 MG sau ɗaya a rana (tare da ko ba tare da abinci ba) na tsawon kwanaki 21, sannan hutu na kwanaki 28 ya biyo baya har zuwa ci gaban cuta ko rashin haƙuri mai guba.
Magana: https://www.fda.gov/
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