Ogosto 2021: Belzutifan (Welireg, Merck), hypoxia-inhibitor factor inhibitor, ayaa oggolaaday Maamulka Cuntada iyo Dawooyinka ee bukaanada qaangaarka ah ee qaba cudurka von Hippel-Lindau ee u baahan daweynta kansarka unugyada kelyaha ee la xiriira (RCC), nidaamka dhexe ee neerfayaasha (CNS) hemangioblastomas, ama burooyinka neeroendokrine (pNET) laakiin uma baahna qalliin degdeg ah.
Belzutifan waxaa lagu baaray 61 bukaan oo qaba VHL-la xiriirta RCC (VHL-RCC) oo lagu ogaaday inay ku saleysan tahay isbeddelka jeermiska VHL iyo ugu yaraan hal buro adag oo la ogaan karo oo ku kooban kelyaha Daraasadda 004 (NCT03401788), baaritaan caafimaad oo summad furan leh. Bukaannada qaba cudurrada kale ee la xiriira VHL, sida CNS hemangioblastomas iyo pNET, ayaa la qoray. Belzutifan 120 mg ayaa la siiyay bukaan -socodka maalintii hal mar ilaa uu cudurku ka sii socdo ama sumoobo aan loo dulqaadan karin.
Heerka jawaabta guud (ORR) ayaa ahaa meesha ugu dambaysa ee waxtarka, sida lagu qeexay qiimeynta shucaaca waxaana qiimeeyay guddi dib -u -eegis madaxbannaan iyadoo la adeegsanayo RECIST v1.1. Muddada jawaab -celinta (DoR) iyo waqtiga jawaab -celinta waxay ahaayeen laba yool oo kale oo waxtar leh (TTR). Shakhsiyaadka leh VCC-da la xiriirta RCC, ORR ah 49% (95 boqolkiiba CI: 36, 62) ayaa la helay. Dhammaan bukaanada qaba VHL-RCC oo helay jawaab ayaa la raadinayay ugu yaraan 18 bilood kadib markii daaweynta la bilaabay. Dhexdhexaadiyaha DoR lama kulmin; 56% jawaabeyaasha waxay lahaayeen DoR ka yar 12 bilood iyo celcelis ahaan TTR oo ah 8 bilood. 24 bukaan oo qaba CNS hemangioblastomas oo la qiyaasi karo ayaa lahaa ORR boqolkiiba 63, iyo 12 bukaan oo leh pNET la qiyaasi karo ayaa ORR ka ahaa 83 boqolkiiba bukaanada qaba VHL-ka kale ee aan ahayn RCC. Loogu talagalay hemangioblastomas CNS iyo pNET, dhexdhexaadiyaha DoR lama kulmin, iyada oo muddadii jawaabta ay ka yaraayeen 12 bilood 73 boqolkiiba iyo 50 boqolkiiba bukaannada, siday u kala horreeyaan.
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 waa in la qaataa hal mar maalintii, cunto ama la'aan, qiyaas ahaan 120 mg.
Tixraaca: https://www.fda.gov/
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