Ogosto 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) waxay ahayd hal-gacan, tijaabo badan oo ka diiwaangashan 112 bukaan oo leh UC heer sare ah ama heer sare ah oo horay u helay kiimiko ku salaysan platinum ama PD-1 ama PD-L1 inhibitor. Maalmaha 1 iyo 8 ee wareegga daaweynta 21-ka maalmood ah, bukaan-socodka ayaa lagu qaatay 10 mg/kg sacituzumab govitecan xididada.
Natiijooyinka wax -ku -oolka ugu weyn waxay ahaayeen heerka jawaab -celinta ujeeddada (ORR) iyo muddada jawaabta (DOR), oo lagu qiimeeyay iyadoo la adeegsanayo RECIST 1.1 shuruudaha dib -u -eegis madaxbannaan. Iyada oo 5.4 boqolkiiba jawaabaha dhammeystiran iyo boqolkiiba 22.3 jawaabaha qayb ahaan, ORR la xaqiijiyay wuxuu ahaa 27.7% (95 boqolkiiba CI: 19.6, 36.9). Dhexdhexaadka DOR (n = 31; 95 boqolkiiba CI: 4.7, 8.6; xadka 1.4+, 13.7) wuxuu ahaa 7.2 bilood.
Neutropenia, lallabbo, shuban, daal, alopecia, dhiig -yaraan, matag, calool -istaag, rabitaanka cuntada oo yaraata, finan, iyo calool -xanuun ayaa ah dhacdooyinka dhinaca ugu badan (dhacdada> 25%) ee bukaannada qaadanaya sacituzumab govitecan.
Ilaa horumarka cudurka ama sumowga aan loo dulqaadan karin, qiyaasta lagu taliyey sacituzumab govitecan waa 10 mg/kg hal mar toddobaadkii maalmaha 1 iyo 8 ee wareegyada daaweynta 21-maalmood ah.
Tixraac: https://www.fda.gov/
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