Nyamavhuvhu 2021: Belzutifan (Welireg, Merck), hypoxia-inducible factor inhibitor, yakatenderwa neKudya neDrug Administration kune vanhu vakuru vane chirwere chevon Hippel-Lindau avo vanoda kurapwa kweiyo renal cell carcinoma (RCC), yepakati system (CNS) hemangioblastomas, kana pancreatic neuroendocrine tumors. (pNET) asi haudi kuvhiyiwa nekukurumidza.
Belzutifan akadzidziswa muvarwere makumi matanhatu nevatanhatu vaneVHL-inosangana neRCC (VHL-RCC) vakaonekwa zvichibva paVHL germline shanduko uye kamwechete bundu rakasimba rinoonekwa rakapfigirwa kuitsvo muChidzidzo che61 chinoramba chiripo (NCT004), yakavhurika-yakatarwa kiriniki kuferefetwa. Varwere vane zvimwe zvinokanganisa zvine hukama neVHL, senge CNS hemangioblastomas uye pNET, vakanyoreswa. Belzutifan 03401788 mg yakapihwa kuvarwere kamwe chete pazuva kudzamara hosha ichiwedzera kana kutapurika kwehuturu.
Iyo yakazara yekupindura mwero (ORR) ndiyo yaive yekutanga kushanda kwekupedzisira, sekutsanangurwa neiyo radiological kuongororwa uye kuongororwa nekomiti yakazvimirira yekuongorora ichishandisa RECIST v1.1. Iyo nguva yekupindura (DoR) uye nguva yekupindura yaive mamwe maviri zvibodzwa zvekuita (TTR). Mune vanhu vane VHL-inosanganisirwa RCC, iyo ORR ye49% (95 muzana CI: 36, 62) yakawanikwa. Vese varwere vane VHL-RCC vaive nemhinduro vakateedzerwa kweinenge mwedzi gumi nemasere mushure mekutanga kurapwa. Iyo yepakati DoR haina kusangana; 18% yevakabvunzwa vaive neDoR isingasviki mwedzi gumi nemaviri uye avhareji TTR yemwedzi misere. 56 varwere vane kuyerwa CNS hemangioblastomas vaive neRR ye12 muzana, uye gumi nevaviri varwere vane kuyerwa pNET vaive neRR ye8 muzana muvarwere vane mamwe maVHL-anosangana asiri-RCC malignancies. Kune CNS hemangioblastomas uye pNET, iyo yepakati DoR haina kusangana, nekupindura kwenguva dzisingasviki mwedzi gumi nemaviri mu24 muzana uye 63 muzana yevarwere, zvichiteerana.
Reduced haemoglobin, anaemia, fatigue, increased creatinine, headache, dizziness, elevated hyperglycemia, and nausea were the most prevalent adverse effects, including laboratory abnormalities, reported in almost 20% of patients who took belzutifan. Belzutifan usage can cause severe anaemia and hypoxia. Anemia was seen in 90% of participants in Study 004, with 7% having Grade 3 anaemia. Patients should be transfused as needed by their doctors. In individuals on belzutifan, the use of erythropoiesis stimulating drugs to treat anaemia is not suggested. Hypoxia occurred in 1.6 percent of patients in Study 004. Belzutifan can make some hormonal contraceptives ineffective, and it can harm an embryo or foetus if taken during pregnancy.
Belzutifan inofanirwa kutorwa kamwe pazuva, kana kana pasina chikafu, mune muyero we120 mg.
Dheuteronomio: https://www.fda.gov/
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