Agasti 2023: I-Pralsetinib (Gavreto, Genentech, Inc.) yanikezwa imvume evamile yi-Food and Drug Administration ezigulini ezikhulile ezinomdlavuza we-RET fusion-positive non-small cell lung cancer (NSCLC), njengoba kunqunywe ukuhlolwa okugunyazwe yi-FDA.
Ngokusekelwe esilinganisweni sokuqala sokuphendula (ORR) kanye nokuqina kwempendulo (DOR) ezigulini ze-114 ezibambe iqhaza ocwaningweni lwe-ARROW (NCT03037385), ukuhlolwa kwe-multicenter, ilebula evulekile, i-multi-cohort, i-pralsetinib yanikezwa imvume esheshayo ye-NSCLC inkomba ngoSepthemba 4, 2020. Ngokusekelwe olwazini oluvela ezigulini ezengeziwe ezingu-123 kanye nezinyanga ezengeziwe ezingu-25 zokulandelela ukuze kulinganiswe ubude besikhathi sempendulo, ukuguqulwa ekugunyazweni okuvamile kwenziwa.
Ingqikithi yeziguli ezingama-237 ezine-NSCLC ethuthuke endaweni noma ezine-metastatic RET fusion-positive zibonise ukusebenza kahle. Iziguli zanikezwa i-pralsetinib kuze kube yilapho isifo siqhubeka noma imiphumela engemihle ingabekezeleleki.
I-Blinded Independent Review Committee (BIRC) yanquma ukuthi i-ORR ne-DOR kwakuyizinyathelo ezibalulekile zokusebenza. I-ORR yayingama-78% (95% CI: 68, 85) phakathi kweziguli eziyi-107 ezingakaze zithole ukwelashwa, kanti i-DOR emaphakathi yayiyizinyanga eziyi-13.4 (95% CI: 9.4, 23.1). I-ORR yayingama-63% (95% CI: 54, 71) phakathi kweziguli ezingu-130 ezazikade zine-chemotherapy esekelwe e-platinum, kanti i-DOR emaphakathi yayiyizinyanga ezingu-38.8 (95% CI: 14.8, engalinganiselwe).
Ukungakhululeki kwemisipha namathambo, ukuqunjelwa, umfutho wegazi ophakeme, isifo sohudo, ukukhathala, i-edoma, i-pyrexia, nokukhwehlela kwakuyimiphumela emibi kakhulu (25%).
I-400 mg ye-pralsetinib ethathwe ngomlomo kanye ngosuku umthamo onconywayo. Kunconywa ukuthi uphuze i-pralsetinib esiswini esingenalutho (akukho ukudla okungenani amahora ama-2 ngaphambi kanye nehora eli-1 ngemuva kokuphathwa kwe-pralsetinib).
