Trifluridine / tipiracil Allunan (LONSURF, Taiho Pharmaceutical Co., Ltd.) sun sami izini daga Hukumar Abinci da Magunguna a ranar 22 ga Fabrairun 2019 don marasa lafiyar manya da ke fama da ciwon ciki ko kuma cinikin gastroesophageal (GEJ) adenocarcinoma wanda aka yi masa magani tare da aƙalla layin adenocarcinomas biyu a baya. .
TAGS (NCT02500043), na kasa da kasa, bazuwar, makafi biyu, gwajin sarrafa wuribo, an karɓa a cikin marasa lafiya 507 tare da ciwon ciki ko GEJ adenocarcinoma waɗanda a baya sun sha aƙalla layin kulawa na chemotherapy guda biyu na baya. An ba da izini ga marasa lafiya 2: 1 don karɓar Lonsurf (n = 337) 35 mg / m2 baki sau biyu kowace rana a Ranakun 1-5 da 8-12 na kowane zagaye na kwanaki 28 tare da kulawa mafi kyawun tallafi (BSC) ko madaidaicin wuribo (n=170). ) tare da BSC har sai cutar ta ci gaba ko rashin yarda da guba.
Matsakaicin matsakaicin matsakaici ga marasa lafiya waɗanda aka yi wa magani tare da Lonsurf ya kasance watanni 5.7 (4.8, 6.2) da kuma watanni 3.6 (3.1, 4.1) ga waɗanda aka kula da su tare da placebo (haɗarin haɗari: 0.69; 95% CI: 0.56, 0.85; p = 0.0006). A cikin marasa lafiya da aka bazu zuwa hannun Lonsurf (haɗarin haɗari 0.56; kashi 95 cikin ɗari CI: 0.46, 0.68; p <0.0001), rashin ci gaban ci gaba ya kasance mafi tsayi.
A cikin rahoton TAGS, neutropenia, anemia, tashin zuciya, rage cin abinci, thrombocytopenia, amai da gudawa sune mafi yawan halayen halayen halayen ko rashin lafiyar dakin gwaje-gwaje (kimanin 10% abin da ya faru) a cikin marasa lafiya da aka bi da Lonsurf, yana faruwa a mafi girma fiye da marasa lafiya da aka bi da su. wuribo.
Abubuwan da aka tsara da jadawalin don Lonsurf shine 35 mg / m2 / kashi sau biyu a rana sau biyu tare da abinci don kowane kwanakin 28 a ranakun 1 zuwa 5 da Ranakun 8 zuwa 12.
View full prescribing information for LONSURF.
FDA ta ba da fifikon wannan aikace-aikacen bita da kuma tantance magungunan marayu. Bayanin shirye-shiryen gaggawa na FDA yana cikin Jagoran Masana'antu: Shirye-shiryen Gaggauwa don Mummunan Yanayi-Magungunna da Halittu.
ƙwararrun ƙwararrun kiwon lafiya yakamata su ba da rahoton duk munanan al'amuran da ake zargin suna da alaƙa da amfani da kowane magani da na'ura zuwa Tsarin Rahoto na MedWatch na FDA ko ta hanyar kiran 1-800-FDA-1088.
