Musi waNdira 14, 2019, cabozantinib (CABOMETYX, Exelixis, Inc.) yakagamuchirwa ne Zvokudya uye Drug Administration kune varwere vane hepatocellular carcinoma (HCC) vakamborapwa nesorafenib.
Kubvumidzwa kwaive kwakavakirwa pane yakasarudzika (2: 1) CELESTIAL (NCT01908426), yakapofomara-mbiri, inochengetwa-placebo-inodzorwa, yakawanda-yakawanda kudzidza muvarwere veHCC avo vakambowana sorafenib uye vaine kukuvara kwechiropa muMwana Pugh Kirasi A. Varwere vakasarudzika kuti vagamuchire. kungave cabozantinib 60 mg kamwe kamwe zuva nezuva nemuromo (n = 470) kana placebo (n = 237) isati yawedzera kukura kwechirwere kana chepfu isina kukodzera.
Chiyero chekutanga chekubudirira kwaive kupona kwese (OS); mamwe matanho emhedzisiro aive kufambira mberi-pasina kupona (PFS) uye yakazara mhinduro mwero (ORR), sekuongororwa nevaongorori paRECIST 1.1. Median OS yaiva mwedzi 10.2 (95% CI: 9.1,12.0) yevarwere vanogamuchira cabozantinib uye 8 mwedzi (95% CI: 6.8, 9.4) kune avo vanogamuchira placebo (HR 0.76; 95% CI: 0.63, 0.92; p = 0.0049). . Median PFS yaive mwedzi 5.2 (4.0, 5.5) uye 1.9 mwedzi (1.9, 1.9), mune cabozantinib uye placebo maoko, zvichiteerana (HR 0.44; 95% CI: 0.36, 0.52; p <0.001). ORR yaive 4% (95% CI: 2.3, 6.0) mu cabozantinib ruoko uye 0.4% (95% CI: 0.0, 2.3) muruwoko rwe placebo.
Diarrhea, kuneta, kuderedza kudya, palmar-plantar erythrodysesthesia, kusvotwa, hypertension, uye kurutsa ndizvo zvinonyanya kuitika zvinowanzoitika munenge 25 muzana yevarwere vakagamuchira cabozantinib mumakiriniki ekuedzwa kuitira kuderedza kuwandisa.
Iyo yakakurudzirwa dhizaini ye cabozantinib ndeye 60 mg muromo, kanenge 1 awa zvisati kana maawa maviri mushure mekudya, kamwe pazuva.
FDA granted this application orphan drug designation. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
