Amaphilisi e-Trifluridine/tipiracil (LONSURF, Taiho Pharmaceutical Co., Ltd.) agunyazwe yi-Food and Drug Administration ngo-February 22, 2019 ezigulini ezikhulile ezine-metastatic gastric noma i-gastroesophageal junction (GEJ) i-adenocarcinoma ngaphambilini elashwe okungenani nge-adenocarcinoma yolayini ababili bangaphambili. , inhlanganisela engaguquki ye-trifluridine, i-nucleoside metabolic inhibitor, ne-tipiracil, i-thymidine phosphorylase inhibitor
I-TAGS (NCT02500043), isilingo samazwe ngamazwe, esingahleliwe, esingaboni kabili, esilawulwa yi-placebo, samukelwe ezigulini ezingama-507 ezine-metastatic gastric noma i-GEJ adenocarcinoma ezazike zathola ukunakekelwa okungenani kwemigqa emibili yangaphambilini yokwelashwa ngamakhemikhali. Iziguli zenziwe ngokungahleliwe i-2: 1 ukuze zithole i-Lonsurf (n = 337) 35 mg / m2 ngomlomo kabili nsuku zonke ngezinsuku ezingu-1-5 kanye ne-8-12 yomjikelezo ngamunye wezinsuku ze-28 ngokunakekelwa okungcono kakhulu okusekela (BSC) noma i-placebo efanayo (n = 170 ) nge-BSC kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki.
Ukusinda okumaphakathi kweziguli eziphathwe nge-Lonsurf kwakuyizinyanga ezingu-5.7 (4.8, 6.2) nezinyanga ezingu-3.6 (3.1, 4.1) kulabo abaphathwa nge-placebo (isilinganiso sengozi: 0.69; 95% CI: 0.56, 0.85; p = 0.0006). Ezigulini ezihlelwe ngokungahleliwe engalweni ye-Lonsurf (isilinganiso sengozi engu-0.56; amaphesenti angu-95 CI: 0.46, 0.68; p<0.0001), ukusinda okungenanqubekela phambili nakho kwakukude.
Embikweni we-TAGS, i-neutropenia, i-anemia, isicanucanu, ukuncipha kwesifiso sokudla, i-thrombocytopenia, ukuhlanza kanye nesifo sohudo kwakuyizimo ezimbi kakhulu ezivame kakhulu noma izinkinga zaselabhorethri (cishe izehlakalo ezilinganiselwa ku-10%) ezigulini ezilashwa nge-Lonsurf, ezenzeka ngenani eliphakeme kuneziguli ezilashwa nge-Lonsurf. indawo ye-placebo.
Umthamo onqunyiwe kanye neshejuli ye-Lonsurf ingu-35 mg/m2/umthamo womlomo kabili ngosuku ngokudla isikhathi ngasinye sezinsuku ezingama-28 Ezinsukwini 1 kuya ku-5 kanye Nezinsuku 8 kuya kwezi-12.
Buka imininingwane egcwele yokunquma ye-LONSURF.
I-FDA inikeze lesi sicelo ukubuyekezwa okubalulekile kanye nokuqokwa kwesidakamizwa sezintandane. Incazelo yezinhlelo ezisheshisiwe ze-FDA iku-Guidance for Industry: Programs Expedited for Serious Conditions-Drugs and 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.
