Nyamavhuvhu 2021: Sacituzumab govitecan (Trodelvy, Immunomedics Inc.) was given accelerated approval by the Food and Drug Administration for patients with locally advanced or metastatic urothelial cancer (mUC) who had previously received platinum-based chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death ligand 1 (PD-L1) inhibitor.
TROPHY (IMMU-132-06; NCT03547973) yaive ruoko-rumwe, multicenter kuyedza iyo yakanyoresa varwere ve112 vane UC yemuno yepamusoro kana metastatic UC avo vakambogamuchira platinum-based chemotherapy uye ingave PD-1 kana PD-L1 inhibitor. Pamazuva 1 ne8 e21-mazuva ekurapa kutenderera, varwere vakagamuchira 10 mg / kg sacituzumab govitecan intravenously.
Mhedzisiro huru yekubudirira yaive yechinangwa chekupindura mwero (ORR) uye nguva yekupindura (DOR), iyo yakaongororwa ichishandisa RECIST 1.1 zviyero neyakaongororwa yakazvimirira. Iine 5.4 muzana mhinduro dzakakwana uye 22.3 muzana mhinduro dzisina kukwana, iyo ORR yakasimbiswa yaive 27.7% (95 muzana CI: 19.6, 36.9). Iyo yepakati DOR (n = 31; 95 muzana CI: 4.7, 8.6; renji 1.4+, 13.7) yaive mwedzi 7.2.
Neutropenia, kuda kurutsa, manyoka, kuneta, alopecia, kupererwa neropa, kurutsa, kuzvimbirwa, kushomeka kwekuda kudya, kuputika, uye kusagadzikana mudumbu ndizvo zviitiko zvakanyanya kudivi (zviitiko> 25%) kune varwere vanotora sacituzumab govitecan.
Kusvikira kukura kwechirwere kana kusashivirika chepfu, iyo yakakurudzirwa sacituzumab govitecan dose ndeye 10 mg / kg kamwe pavhiki pamazuva 1 uye 8 ezuva makumi maviri nemasere ekurapa kutenderera.
Referensi: https://www.fda.gov/
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