Belzutifan inotenderwa neUSFDA kune advanced renal cell carcinoma

Belzutifan inotenderwa neUSFDA kune advanced renal cell carcinoma

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Chikafu neDrug Administration yakapa mvumo yebelzutifan (Welireg, Merck & Co., Inc.) muna Zvita 14, 2023, kune varwere vane advanced renal cell carcinoma (RCC) vakambogamuchira chirongwa chekufa receptor-1 (PD-1) ) kana kuti programmed death-ligand 1 (PD-L1) inhibitor uye vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

Kubudirira kwakaongororwa muLITESPARK-005 (NCT04195750), chidzidzo apo 746 varwere vane unrectable munharaunda yepamusoro kana metastatic clear cell RCC vakaiswa zvisina kurongwa kurapwa kwakasiyana mushure mekufambira mberi kutevera PD-1 kana PD-L1 checkpoint inhibitor uye VEGF-TKI. . Vatori vechikamu vakagoverwa muchikamu che1: 1 kuti vagamuchire 120 mg yebelzutifan kana 10 mg yeeverolimus kamwe chete pazuva. Randomization yakarongedzerwa maererano neInternational Metastatic RCC Database Consortium njodzi boka uye huwandu hwevakapfuura VEGF-TKIs.

Matanho ekutanga ekubudirira aive kufambira mberi-kusina kupona (PFS) yakaongororwa nekupofumadzwa yakazvimirira yepakati ongororo uye kupona kwese (OS).

Belzutifan yakaratidza kuvandudzika kwakakosha mukufambira mberi-pasina kupona (PFS) zvichienzaniswa neeverolimus, ine hazard ratio ye0.75 (95% CI: 0.63, 0.90) uye imwe-sided p-value ye0.0008. Iyo Kaplan-Meier macurves airatidza kusaenzana kwenjodzi neinofananidzwa yepakati kufambira mberi-yemahara fungidziro yekupona kwemwedzi 5.6 (95% CI: 3.9, 7.0) mu belzutifan boka uye mwedzi 5.6 (95% CI: 4.8, 5.8) muboka re everolimus. Kunyangwe iyo data yeOS yanga isina kukwana pachidzidzo chazvino, ne59% yevakafa yakataurwa, hapana maitiro asina kunaka akaonekwa. Kuongororwa kwezviratidzo zvakashumwa nemurwere nemigumisiro yekushanda kwakaratidza kuti belzutifan yakanga yakabvumirwa zviri nani kupfuura everolimus.

Mhedzisiro yakashata (≥25% chiitiko) yakaonekwa muvarwere vanobatwa nebelzutifan yaisanganisira kuderedzwa kwemazinga ehemoglobin, kuneta, kurwadziwa kwemusculoskeletal, kukwirira kwecreatinine mazinga, kuderera kwe lymphocyte count, yakakwira alanine aminotransferase mazinga, yakaderedzwa sodium mazinga, yakakwira potassium mazinga, uye yakawedzera aspartate. aminotransferase mazinga.

Iyo yakakurudzirwa belzutifan dosage ndeye 120 mg inotorwa nemuromo kamwe chete pazuva kusvika kufambira mberi kwechirwere kana huturu husingagoneki.

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