Nuwamba 2021: Hukumar Abinci da Magunguna ta amince atezolizumab (Tecentriq, Genentech, Inc.) don maganin adjuvant a cikin marasa lafiya tare da mataki na II zuwa IIIA marasa ciwon huhu na huhu (NSCLC) wanda ciwace-ciwacen su ya ƙunshi maganganun PD-L1 akan kasa da 1% na ƙwayoyin tumo, kamar yadda aka tantance ta hanyar gwajin da aka yarda da FDA.
VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems, Inc.) Hakanan an ba da izini ta FDA a yau azaman na'urar tantancewar abokin tarayya don zaɓar marasa lafiya tare da NSCLC don jiyya tare da Tecentriq.
Rayuwa mara lafiya (DFS) shine ma'aunin sakamako mai mahimmanci, kamar yadda mai binciken ya ƙaddara a cikin ƙididdigar ƙimar ƙimar farko (n=476) na marasa lafiya tare da mataki na II-IIIA NSCLC tare da maganganun PD-L1 akan 1% na ƙwayoyin ƙari ( PD-L1 1% TC). A cikin hannun atezolizumab, Median DFS ba a kai ba (95 bisa dari CI: 36.1, NE) idan aka kwatanta da watanni 35.3 (95 bisa dari CI: 29.0, NE) a cikin hannun BSC (HR 0.66; 95 bisa dari CI: 0.50, 0.88; p= 0.004).
DFS HR ya kasance 0.43 a cikin ƙididdigar rukuni na biyu da aka riga aka ƙayyade na marasa lafiya tare da PD-L1 TC 50% mataki II-IIA NSCLC (95 bisa dari CI: 0.27, 0.68). DFS HR ya kasance 0.87 a cikin binciken ƙungiyar bincike na marasa lafiya tare da PD-L1 TC 1-49 kashi mataki II-IIA NSCLC (95 bisa dari CI: 0.60, 1.26).
Ƙara aspartate aminotransferase, jini creatinine, da alanine aminotransferase, kazalika da hyperkalemia, rash, tari, hypothyroidism, pyrexia, gajiya / asthenia, musculoskeletal zafi, peripheral neuropathy, arthralgia, da pruritus, sun kasance mafi na kowa (kashi goma) m halayen a ciki. marasa lafiya da ke karɓar atezolizumab, gami da rashin daidaituwa na dakin gwaje-gwaje.
Don wannan nuni, shawarar da aka ba da shawarar atezolizumab shine 840 MG kowane mako biyu, 1200 MG kowane mako uku, ko 1680 MG kowane mako huɗu har zuwa shekara guda.
