Nuwamba 2023: Hukumar Abinci da Magunguna (FDA) ta amince da Ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) a cikin Nuwamba 2023 don kula da tsofaffi marasa lafiya tare da sake dawowa ko cututtukan myelodysplastic (MDS) waɗanda ke da raunin isocitrate dehydrogenase-1 (IDH1) maye gurbin bisa ga Gwajin da FDA ta amince.
FDA ta kuma amince da Abbott RealTime IDH1 Assay azaman kayan aikin bincike na abokin aiki don zaɓar marasa lafiya don karɓar ivosidenib.
Amincewa ya dogara ne akan AG120-C-001 (NCT02074839), hannu guda ɗaya, alamar buɗaɗɗe, gwaji mai yawa tare da marasa lafiya 18 masu girma waɗanda suka sake dawowa ko MDS da kuma maye gurbin IDH1. An gano maye gurbin IDH1 ta hanyar yin amfani da gwaje-gwajen bincike na gida ko na tsakiya a cikin jini na gefe ko kasusuwa, kuma daga baya an inganta su ta hanyar bincike na baya ta yin amfani da Abbott RealTime IDH1 Assay.
An yi amfani da inosidenib na baka a farkon kashi na 500 MG kowace rana a ci gaba da salon har tsawon kwanaki 28, ko har sai dashen kwayar cutar hematopoietic, ci gaban cuta, ko guba mara yarda ya faru. Matsakaicin lokacin jiyya shine watanni 9.3. Bayan karbar ivosidenib, an yi dashen kwayar halitta a kan majiyyaci daya.
Adadin tafiya daga buƙatar ƙarin ƙarin jini zuwa rashin buƙatar su, ƙimar cikakkiyar gafara (CR) ko remission partial (PR) (2006 International Working Group martani ga MDS), da tsayin CR + PR an yi amfani da su don yin hukunci da kyau. magani yayi aiki. Kowane martani da aka lura ya ƙunshi CR. 389.9% shine ƙimar CR (95% CI: 17.3, 64.3%). Matsakaicin lokacin-zuwa-CR shine watanni 1.9, tare da kewayon 1.0 zuwa watanni 5.6. Koyaya, ba za a iya ƙididdige lokacin tsaka-tsaki na CR ba, wanda ke tsakanin watanni 1.9 zuwa 80.8+. Daga cikin marasa lafiya tara da suka fara dogaro da kwayar cutar jajayen jini (RBC) da kuma jigilar platelet, shida (67%) sun sami 'yancin kai daga RBC da transfusions na platelet a cikin kowane kwanaki 56 bayan asali. Bakwai daga cikin marasa lafiya tara waɗanda ba su da ƙarin jini a cikin tushe, gami da platelet da transfusions na RBC, sun kasance marasa jini ga kowane lokaci na kwanaki 56 bayan lokacin asali (kashi 78).
Kwatankwacin halayen halayen da aka saba gani akai-akai tare da ivosidenib monotherapy don AML, waɗannan sune halayen halayen da suka fi yawa akai-akai. Baya ga gastrointestinal (maƙarƙashiya, tashin zuciya, arthralgia, lethargy, tari, da myalgia), waɗannan alamun sun haɗa da kurji da arthralgia. Tibsovo kuma na iya tsawaita QTc.
An haɗa Gargadin Akwati a cikin bayanan da aka ba da izini don gargaɗin marasa lafiya da ƙwararrun kula da lafiya game da haɗarin bambance-bambancen da ke iya yin kisa.
Dubi cikakkun bayanan rubutawa na Tibsovo.
