Yuni 2022: Ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) A hade tare da azacitidine an yarda da Cibiyar Abinci da Magunguna don sabon kamuwa da cutar sankarar bargo mai cutar sankara (AML) a cikin manya masu shekaru 75 ko sama da haka tare da maye gurbin IDH1 mai saukin kamuwa, kamar yadda gwajin da FDA ta amince da shi, ko kuma waɗanda ke da cututtukan da ke hana kamuwa da cuta mai ƙarfi. induction chemotherapy.
FDA ta ba da izini dangane da sakamakon bazuwar, cibiyar da yawa, makafi biyu, binciken sarrafa wuribo (AG120-C-009, NCT03173248) wanda ya sanya marasa lafiya 146 tare da sabon AML da aka gano tare da maye gurbin IDH1 wanda ya gamsu da aƙalla ɗaya daga cikin sharuɗɗan masu biyowa: shekaru 75 ko sama da haka, Matsayin aikin ECG 2, babban cututtukan zuciya ko cututtukan huhu, nakasa hanta tare da bilirubin> sau 1.5 na babba na al'ada, izinin creatinine 45 mL / min, ko sauran cututtukan cututtukan cututtukan A cikin Kwanaki 1-28, marasa lafiya An bazuwar 1: 1 don karɓar ivosidenib 500 MG kowace rana (N=72) ko madaidaicin placebo baki sau ɗaya kowace rana (N=74) tare da azacitidine 75 mg/m2/rana a Ranakun 1-7 ko Kwanaki 1-5 da 8 -9 na kowane 28-day sake zagayowar har sai cuta ta ci gaba, rashin yarda da guba, ko hematopoietic stem cell transplantation har sai cutar ta ci gaba, guba mara yarda, ko hematopoietic stem cell transplantation.
An yi amfani da ingantattun rayuwa ba tare da aukuwa ba (EFS), rayuwa gabaɗaya (OS), da ƙima da tsawon lokacin cikakken gafara don tantance inganci (CR). Lokacin daga bazuwar zuwa gazawar jiyya, komawa daga gafara, ko mutuwa daga kowane dalili, duk wanda ya fara zuwa, ana kiransa EFS. Rashin samun CR a cikin makonni 24 an dauki shi azaman gazawar jiyya. EFS ya faru a cikin kashi 65 na ivosidenib tare da marasa lafiya azacitidine da 84 bisa dari na placebo da marasa lafiya azacitidine (HR 0.35; 95 bisa dari CI: 0.17, 0.72, p=0.0038). Tsakanin OS a cikin ivosidenib da hannu azacitidine shine watanni 24.0 (95 bisa dari CI: 11.3, 34.1), yayin da placebo da azacitidine hannu ya kasance watanni 7.9 (95 bisa dari CI: 4.1, 11.3) (HR 0.44; 95% CI: 0.27). 0.73; p=0.0010). Adadin CR a cikin ivosidenib tare da hannu azacitidine shine kashi 47 (95 bisa dari CI: 35 bisa dari, 59 bisa dari) da kashi 15 (95 bisa dari CI: 8 bisa dari, 25 bisa dari) a cikin placebo da azacitidine hannu. Tsawon tsaka-tsaki na CR a cikin ivosidenib da hannu azacitidine ba a ƙididdigewa ba (NE) (tazarar amincewa da kashi 95: 13.0, NE) da watanni 11.2 (tazarar amincewa da kashi 95: 3.2, NE) a cikin placebo da hannu azacitidine.
Zawo, gajiya, edema, tashin zuciya, amai, rage cin abinci, leukocytosis, arthralgia, dyspnea, ciwon ciki, mucositis, rash, electrocardiogram QT tsawaita, bambance-bambancen ciwo, da myalgia su ne mafi yawan m halayen ivosidenib a hade tare da azacitidine ko a matsayin monotherapy. (25 bisa dari a kowace gwaji). Gargadi na Akwati akan umarnin rubutawa ya gargaɗi ƙwararrun ma'aikatan kiwon lafiya da marasa lafiya game da yuwuwar kamuwa da ciwon bambance-bambance, wanda zai iya zama mai kisa ko kuma yana da haɗari.
An wajabta Ivosidenib a kashi na 500 MG sau ɗaya kowace rana, tare da ko ba tare da abinci ba, har sai cutar ta ci gaba ko kuma rashin yarda da guba. A Ranakun 1-7 (ko Kwanaki 1-5 da 8-9) na kowane zagayowar kwanaki 28, fara gudanar da ivosidenib tare da azacitidine 75 mg/m2 subcutaneously ko kuma ta hanji sau ɗaya kowace rana. Ana ba da shawarar jiyya don aƙalla watanni 6 ga marasa lafiya ba tare da ci gaban rashin lafiya ba ko babban guba don ba da lokacin amsawar asibiti.
Dubi cikakkun bayanan rubutawa na Tibsovo
