Trifluridine / tipiracil mapiritsi (LONSURF, Taiho Pharmaceutical Co, Ltd.) akagamuchirwa neKudya neDrug Administration musi waFebruary 22, 2019 yevakuru varwere vane metastatic gastric kana gastroesophageal junction (GEJ) adenocarcinoma yakamborapwa neanenge maviri epamberi mutsara adenocarcinomas. , yakasanganiswa mubatanidzwa wetrifluridine, nucleoside metabolic inhibitor, uye tipiracil, thymidine phosphorylase inhibitor.
TAGS (NCT02500043), muedzo wepasi rose, wakasarudzika, wakapetwa kaviri-mapofu, wakagamuchirwa muvarwere ve507 vane metastatic gastric kana GEJ adenocarcinoma avo vakamboita kanenge maviri apfuura chemotherapy mitsara yekutarisira. Varwere vakarongeka 2: 1 kuti vagamuchire Lonsurf (n = 337) 35 mg / m2 nemuromo kaviri zuva nezuva paMazuva 1-5 uye 8-12 yega yega 28-zuva kutenderera nekunakisisa kutsigira kuchengetedza (BSC) kana kuenzanisa placebo (n = 170 ) neBSC kusvika chirwere chakura kana huturu husingagamuchirwi.
Wepakati wepakati kupona kwevarwere vanobatwa neLonsurf yaive mwedzi 5.7 (4.8, 6.2) uye 3.6 mwedzi (3.1, 4.1) yeavo vanorapwa ne placebo (hazard ratio: 0.69; 95% CI: 0.56, 0.85; p = 0.0006). Mune varwere vakasarudzika kune iyo Lonsurf ruoko (hazard ratio 0.56; 95 muzana CI: 0.46, 0.68; p <0.0001), kufambira mberi-kwemahara kupona kwaive zvakareba.
Mumushumo weTAGS, neutropenia, kupererwa neropa, kusvotwa, kuderera kwekuda kudya, thrombocytopenia, kurutsa uye manyoka ndiyo yainyanya kukonzeresa maitiro kana ma laboratory anomalies (inenge 10% chiitiko) muvarwere vanobatwa neLonsurf, zvichiitika pamwero wakakwira kupfuura muvarwere vanorapwa. placebo.
Iyo yakatemwa muyero uye chirongwa cheLonsurf ndeye 35 mg / m2 / dhizaini muromo kaviri pazuva nechikafu chega chega chemazuva makumi maviri nemasere paMazuva 28 kusvika pa1 uye Mazuva 5 kusvika gumi nemaviri.
View full prescribing information for LONSURF.
FDA yakapa ichi chikumbiro chekutanga kuongororwa uye zita remishonga yenherera. Tsananguro yezvirongwa zveFDA zvakakurumidza zviri muNhungamiro yeIndasitiri: Expedited Zvirongwa zveSerious Conditions-Drugs uye Biologics.
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.
