Jan 2022: Pembrolizumab (Keytruda, Merck) Cibiyar Abinci da Magunguna ta amince da ita don kula da marasa lafiya tare da ciwon daji na renal cell (RCC) waɗanda ke cikin tsaka-tsaki ko babban haɗari na sake dawowa bayan nephrectomy, ko bayan nephrectomy tare da resection na metastatic raunuka.
An yi la'akari da inganci a cikin marasa lafiya na 994 tare da tsaka-tsaki ko babban haɗari na sake dawowa na RCC, ko M1 babu alamar rashin lafiya, a cikin KEYNOTE-564 (NCT03142334), mai yawa, bazuwar (1: 1), makafi biyu, mai sarrafa wuribo. gwaji. An ba marasa lafiya ko dai pembrolizumab 200 MG a cikin jini a kowane mako 3 ko placebo har zuwa shekara guda, ko kuma har sai rashin lafiya ya sake dawowa ko rashin iya jurewa, duk wanda ya fara.
Rayuwa marar cuta (DFS), wanda aka ayyana azaman lokaci tsakanin maimaitawa, metastasis, ko mutuwa, shine ma'aunin sakamako na farko. Gabaɗaya rayuwa wani ma'aunin sakamako ne (OS). Wani ƙayyadadden ƙididdiga na wucin gadi ya nuna ingantaccen ingantaccen ƙididdiga a cikin DFS, tare da abubuwan da suka faru na 109 (22%) a cikin hannu na pembrolizumab da abubuwan 151 (30%) a cikin hannun placebo (HR 0.68; 95 bisa dari CI: 0.53, 0.87; p=0.0010) . A ko wanne hannu, an kai tsakiyar DFS. Bayanan OS ba su cika ba a lokacin binciken DFS, tare da 5% na yawan jama'a suna mutuwa.
Rashin jin daɗi na tsoka, gajiya, kurji, zawo, pruritus, da hypothyroidism sune mafi yawan illolin da ke cikin wannan gwaji (kashi 20).
Ana ba da Pembrolizumab a cikin allurai na 200 MG kowane mako uku ko 400 MG kowane mako shida har sai cutar ta sake dawowa, rashin jurewa, ko har zuwa watanni 12.
Click here for full prescribing information for Keytruda.
