Agusta 2021: Sacituzumab govitecan (Trodelvy, Immunomedics Inc.) Cibiyar Abinci da Magunguna ta ba da izinin haɓakawa ga marasa lafiya da ke da ci gaba na gida ko ciwon daji na urothelial (mUC) waɗanda a baya sun karɓi maganin cutar sankara na platinum kuma ko dai mai karɓar mai karɓar mutuwa-1 (PD-1) ko shirin mutuwa ligand 1 ( PD-L1) mai hanawa.
TROPHY (IMMU-132-06; NCT03547973) wani hannu ne guda ɗaya, gwaji na tsakiya wanda ya shigar da marasa lafiya 112 tare da ci gaba a cikin gida ko metastatic UC waɗanda a baya sun karɓi maganin cutar sankara na platinum kuma ko dai PD-1 ko PD-L1 mai hanawa. A ranakun 1 da 8 na sake zagayowar kwanaki 21, marasa lafiya sun karɓi 10 mg/kg sacituzumab govitecan intravenously.
Babban sakamako masu tasiri shine ƙimar amsawar haƙiƙa (ORR) da tsawon lokacin amsawa (DOR), waɗanda aka tantance ta amfani da ma'aunin RECIST 1.1 ta bita mai zaman kanta. Tare da 5.4 bisa dari cikakke amsa da 22.3 kashi na ɓangaren amsa, ORR da aka tabbatar shine 27.7% (95 bisa dari CI: 19.6, 36.9). Matsakaicin DOR (n=31; 95 bisa dari CI: 4.7, 8.6; kewayon 1.4+, 13.7) ya kasance watanni 7.2.
Neutropenia, tashin zuciya, zawo, lethargy, alopecia, anemia, amai, maƙarƙashiya, rage cin abinci, rash, da rashin jin daɗi na ciki shine mafi yawan abubuwan da ke faruwa a gefe (abin da ya faru> 25%) a cikin marasa lafiya da ke shan sacituzumab govitecan.
Har sai cutar ta ci gaba ko cutar da ba za a iya jurewa ba, shawarar sacituzumab govitecan kashi shine 10 mg/kg sau ɗaya a mako a ranakun 1 da 8 na hawan keke na kwana 21.
Magana: https://www.fda.gov/
Duba cikakkun bayanai nan.
