Jan 2023: Umuthi I-nadofaragene firadenovec-vncg (Adstiladrin, Ferring Pharmaceuticals) kugunyazwe i-Food and Drug Administration yeziguli ezikhulile ezinomdlavuza wesinye oyingozi kakhulu, ongaphenduli (i-NMIBC) one-carcinoma in situ (CIS) enamaqhubu e-papillary noma engenawo.
Ku-Study CS-003 (NCT02773849), ukuhlolwa kwe-multicenter, kwengalo eyodwa okubandakanya iziguli ze-157 ezine-NMIBC ezinobungozi obukhulu kanye ne-98 yazo ene-CIS engahlolwa ukuze iphendule, ukusebenza kahle kwahlolwa. Kanye njalo ezinyangeni ezintathu kuze kufike ezinyangeni eziyi-12, ubuthi obungabekezeleleki, noma i-NMIBC yezinga eliphezulu eqhubekayo, iziguli zithole i-nadofaragene firadenovec-vncg 75 mL instillation intravesical (3 x 1011 viral particles/mL [vp/mL]). Iziguli zazivunyelwe ukuqhubeka zithole i-nadofaragene firadenovec-vncg njalo ezinyangeni ezintathu inqobo nje uma kungekho ukuphindaphinda kwebanga eliphezulu.
Ukuphendula okuphelele (CR) nganoma yisiphi isikhathi nokuqina kwempendulo bekungamamethrikhi omphumela wokusebenza ngempumelelo (DoR). Ukuze ufaneleke njenge-CR, i-cystoscopy engalungile kanye ne-TURBT efanelekile, ama-biopsies, ne-cytology yomchamo yayidingeka. Ama-biopsies esinye amahlanu ahlukene athathwe ngokungahleliwe ezigulini ezaziseku-CR ngemva konyaka. I-DoR emaphakathi yayiyizinyanga ezingu-9.7 (uhla: 3, 52+), izinga le-CR lalingu-51% (95% CI: 41%, 61%), futhi u-46% weziguli ezisabelayo zahlala ku-CR okungenani unyaka.
Ukwanda kwe-hyperglycemia, ukukhishwa kwendawo yokufaka, ukukhuphuka kwe-triglycerides, ukukhathala, i-spasm yesinye, ukuphuthuma kwe-micturition, ukukhuphuka kwe-creatinine, i-hematuria, ukuncipha kwe-phosphate, ukugodola, i-dysuria, ne-pyrexia kwakuyimiphumela emibi kakhulu (isigameko esingu-10%), kanye nokungajwayelekile kokuhlolwa. > 15%).
Usebenzisa i-catheter yomchamo, faka u-75 mL we-nadofaragene firadenovec-vncg esinyeni kanye njalo ezinyangeni ezintathu ekuhlanganiseni okungu-3 x 1011 vp/mL. Kunconywa ukuthatha i-anticholinergic njenge-premedication ngaphambi kokufakwa ngakunye.
