A ranar 14 ga Janairu, 2019, cabozantinib (CABOMETYX, Exelixis, Inc.) ya amince da Abinci da Drug Administration ga marasa lafiya da ciwon hepatocellular carcinoma (HCC) waɗanda aka yi amfani da su a baya tare da sorafenib.
Amincewar ta dogara ne akan bazuwar (2: 1) CELESTIAL (NCT01908426), makafi biyu, sarrafa wuribo, nazarin multicenter a cikin marasa lafiyar HCC waɗanda suka sami sorafenib a baya kuma suna da cutar hanta a cikin Yara Pugh Class A. Marasa lafiya bazuwar karɓar ko dai cabozantinib 60 MG sau ɗaya a baki (n = 470) ko placebo (n = 237) kafin ɓarna na cuta ko ƙarancin guba.
Babban ma'aunin inganci shine gaba ɗaya rayuwa (OS); ƙarin matakan sakamako sune tsira ba tare da ci gaba ba (PFS) da ƙimar amsa gabaɗaya (ORR), kamar yadda masu bincike suka tantance ta kowace RECIST 1.1. Median OS shine watanni 10.2 (95% CI: 9.1,12.0) ga marasa lafiya da ke karɓar cabozantinib da watanni 8 (95% CI: 6.8, 9.4) ga waɗanda ke karɓar placebo (HR 0.76; 95% CI: 0.63, 0.92; p=0.0049) . Median PFS shine watanni 5.2 (4.0, 5.5) da watanni 1.9 (1.9, 1.9), a cikin cabozantinib da placebo makamai, bi da bi (HR 0.44; 95% CI: 0.36, 0.52; p <0.001). ORR ya kasance 4% (95% CI: 2.3, 6.0) a cikin hannun cabozantinib da 0.4% (95% CI: 0.0, 2.3) a cikin hannun placebo.
Zawo, gajiya, rage cin abinci, palmar-plantar erythrodysesthesia, tashin zuciya, hauhawar jini, da amai sune halayen da suka fi yawa a cikin kusan kashi 25 na marasa lafiya waɗanda suka karɓi cabozantinib a gwaji na asibiti don rage yawan mita.
Gwargwadon shawarar cabozantinib shine MG 60 a baki, aƙalla awa 1 kafin ko sa'o'i 2 bayan cin abinci, sau ɗaya a rana.
FDA ba da wannan aikace-aikacen sanya marayan maraya Ya kamata kwararrun likitocin kiwon lafiya su bayar da rahoton duk wasu munanan abubuwan da suka faru wadanda ake zargi da alaka da amfani da kowane magani da na'ura ga FDA Tsarin Rahoton MedWatch ko ta kiran 1-800-FDA-1088.
