Agasti 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.
I-TROPHY (IMMU-132-06; NCT03547973) kwakuyisivivinyo sengalo eyodwa, esinezikhungo eziningi esabhalisa iziguli eziyi-112 ezine-UC ethuthukisiwe yasendaweni noma ene-metastatic eyayithole ngaphambilini i-chemotherapy esekelwe ku-platinum kanye ne-PD-1 noma i-PD-L1 inhibitor. Ngosuku loku-1 nolwesi-8 lomjikelezo wokwelapha wezinsuku ezingama-21, iziguli zathola u-10 mg/kg we-sacituzumab govitecan ngomjovo.
Imiphumela emikhulu yokusebenza kahle kwakuyizinga lokuphendula lenhloso (ORR) kanye nobude besikhathi sokuphendula (DOR), ezihlolwe kusetshenziswa imibandela ye-RECIST 1.1 ngokubuyekezwa okuzimele. Ngezimpendulo eziphelele zamaphesenti angu-5.4 kanye nezimpendulo eziyingxenye yamaphesenti angu-22.3, i-ORR eqinisekisiwe yayingu-27.7% (amaphesenti angu-95 CI: 19.6, 36.9). I-DOR emaphakathi (n=31; 95 amaphesenti CI: 4.7, 8.6; ububanzi 1.4+, 13.7) bekuyizinyanga ezingu-7.2.
I-Neutropenia, isicanucanu, isifo sohudo, ukukhathala, i-alopecia, i-anemia, ukuhlanza, ukuqunjelwa, ukuncipha kwesifiso sokudla, ukuqubuka, nokuphatheka kabi kwesisu yizigameko ezivame kakhulu eziseceleni (isigameko>>25%) ezigulini ezithatha i-sacituzumab govitecan.
Kuze kube ukukhula kwesifo noma ubuthi obungabekezeleleki, umthamo we-sacituzumab govitecan onconywayo ungu-10 mg / kg kanye ngesonto ngezinsuku 1 no-8 zemijikelezo yokwelashwa yezinsuku ezingama-21.
Inkomba: https://www.fda.gov/
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