I-Food and Drug Administration inikeze imvume ye-belzutifan (Welireg, Merck & Co., Inc.) ngomhla ka-14 Disemba 2023, ezigulini ezine-advanced renal cell carcinoma (RCC) ezithole ngaphambilini i-programmed death receptor-1 (PD-1) ) noma i-death-ligand 1 (PD-L1) inhibitor ehleliwe kanye ne-vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
Ukusebenza kwahlolwa ku-LITESPARK-005 (NCT04195750), ucwaningo lapho iziguli ezingu-746 ezine-RCC ehlanzekile yendawo ethuthukisiwe noma ye-metastatic ecacile zabelwa ngokungahleliwe ekwelashweni okuhlukile ngemva kokuqhubeka nokulandela i-PD-1 noma i-PD-L1 yokuhlola inhibitor kanye ne-VEGF-TKI. . Abahlanganyeli babelwa ngokungahleliwe ngesilinganiso esingu-1:1 ukuze bathole u-120 mg we-belzutifan noma u-10 mg we-everolimus kanye ngosuku. Ukungahleliwe kufakwe kusigaba ngokusekelwe eqenjini lengcuphe le-International Metastatic RCC Database Consortium kanye nenani lama-VEGF-TKIs adlule.
Izinyathelo eziyinhloko ezisebenzayo kwakuyi-progression-free survival (PFS) ehlolwe ukubuyekezwa okuzimele okuphuphuthekile kanye nokusinda okuphelele (OS).
I-Belzutifan ibonise ukuthuthuka okuphawulekayo kwezibalo ekusindeni kwe-progression-free (PFS) uma kuqhathaniswa ne-everolimus, enesilinganiso sengozi esingu-0.75 (95% CI: 0.63, 0.90) kanye nevelu yohlangothi olulodwa lwe-p engu-0.0008. Amajika e-Kaplan-Meier abonise ubungozi obungalingani nezilinganiso zokusinda ezingenayo ukuqhubeka ezimaphakathi zezinyanga ezingu-5.6 (95% CI: 3.9, 7.0) ku- i-belzutifan iqembu kanye nezinyanga ezingu-5.6 (95% CI: 4.8, 5.8) eqenjini le-everolimus. Nakuba idatha ye-OS ibingaphelele ocwaningweni lwamanje, njengoba kubikiwe abantu abangu-59% abashonile, akukho mkhuba omubi otholakele. Ukuhlolwa kwezimpawu ezibikwe ngesiguli kanye nemiphumela yokusebenza kwabonisa ukuthi i-belzutifan yayibekezelelwa kangcono kune-everolimus.
Imiphumela emibi evelele (≥25% ukwenzeka) ebonwa ezigulini ezelashwa nge-belzutifan ihlanganisa amazinga e-hemoglobin ancishisiwe, ukukhathala, ubuhlungu be-musculoskeletal, amazinga aphezulu e-creatinine, ukwehla kwesibalo se-lymphocyte, amazinga aphezulu e-alanine aminotransferase, ukunciphisa amazinga e-sodium, amazinga aphezulu e-potassium, nokwanda kwe-aspartate. amazinga e-aminotransferase.
Umthamo ophakanyisiwe we-belzutifan ngu-120 mg othathwa ngomlomo kanye ngosuku kuze kube yilapho isifo siqhubeka noma ubuthi obungabekezeleleki.
Cancer
I-Lutetium Lu 177 dotatate igunyazwe yi-USFDA yeziguli zezingane ezineminyaka engu-12 nangaphezulu nge-GEP-NETS
I-Lutetium Lu 177 dotatate, ukwelashwa okuyisimangaliso, isanda kuthola imvume evela kwa-US Food and Drug Administration (FDA) yeziguli zezingane, okumaka ingqopha-mlando ku-oncology yezingane. Lokhu kugunyazwa kumelele ukukhanya kwethemba ezinganeni ezilwa nezimila ze-neuroendocrine (NETs), uhlobo lomdlavuza oluyivelakancane kodwa oluyinselele oluvame ukufakazela ukumelana nemithi evamile.
Alysha Mendossa
Kwangathi 11, 2024
