Agusta 2023: Maganin balagagge marasa lafiya tare da sabuwar cutar sankarar cutar sankarar myeloid (AML) wacce ke FLT3 na ciki tandem kwafi (ITD) -tabbatacce, kamar yadda gwajin da aka yarda da FDA ya gano, tare da induction na cytarabine da anthracycline daidai da haɓakar cytarabine, da kiyayewa. monotherapy biyo bayan haɓakar chemotherapy, Hukumar Abinci da Magunguna ta amince da ita.
LeukoStrat CDx FLT3 Mutation Assay an kuma ba shi amincewar FDA azaman gwajin abokin tarayya na Vanflyta.
A cikin QuANTUM-First (NCT02668653), bazuwar, makafi biyu, gwajin sarrafa wuribo wanda ya shafi marasa lafiya 539 tare da sabon kamuwa da FLT3-ITD tabbatacce AML, an tantance tasirin quizartinib a hade tare da chemotherapy. A gwajin gwaji An yi amfani da assay don tabbatar da matsayin FLT3-ITD mai zuwa, kuma an yi amfani da gwajin gwajin LeukoStrat CDx FLT3 Mutation Assay don tabbatar da shi bayan gaskiyar.
Bisa ga aikin farko, marasa lafiya sun kasance bazuwar (1: 1) don karɓar quizartinib (n = 268) ko placebo (n = 271) tare da ƙaddamarwa, ƙarfafawa, da kuma kulawa da monotherapy. A farkon jiyya bayan ƙarfafawa, babu sake bazuwar. Bayan farfadowar hematopoietic stem cell (HSCT), marasa lafiya da suka yi HSCT sun fara aikin kulawa.
Gabaɗaya rayuwa (OS), ƙididdiga daga ranar bazuwar har zuwa mutuwa daga kowane dalili, yayi aiki azaman ma'aunin sakamako na farko. Bayan akalla watanni 24 sun wuce tun lokacin da aka ba da haƙuri na ƙarshe ba da gangan ba, an gudanar da babban bincike. A cikin gwaji, hannun quizartinib ya nuna haɓakar ƙididdiga a cikin OS [haɗari (HR) 0.78; 95% CI: 0.62, 0.98; 2 gefe p=0.0324]. Tare da tsawon lokaci na watanni 38.6 (95% CI: 21.9, NE), ƙimar CR na quzartinib hannun shine 55% (95% CI: 48.7, 60.9), kuma ƙimar CR na ƙungiyar placebo shine 55% (95% CI: 49.2) , 61.4) tare da tsawon lokaci na watanni 12.4 (95% CI: 8.8, 22.7).
Bayan allogeneic HSCT, quizartinib ba a ba da shawarar azaman kulawa da monotherapy ba. Ba a nuna Quiartinib don haɓaka OS a cikin wannan yanayin ba.
Tsawaita QT, torsades de pointes, da kamun zuciya duk an ambata su a cikin akwatin gargadi na quizartinib. Vanflyta REMS ne kawai, ƙayyadaddun shirin a ƙarƙashin Tsarin Haɗari da Rage Hatsari (REMS), yana ba da quizartinib. Don cikakken jerin abubuwan illa, tuntuɓi bayanan da aka tsara.
Adadin quizartinib da aka ba da shawarar shine kamar haka:
- Gabatarwa: 35.4 MG na baki sau ɗaya a rana a ranakun 8-21 na "7 + 3" (cytarabine [100 ko 200 mg / m2 / rana] a ranakun 1 zuwa 7 da daunorubicin [60 mg / m2 / day] ko idarubicin [12 mg /m2/rana] a ranakun 1 zuwa 3) da kuma a ranakun 8-21 ko 6-19 na zaɓi na biyu na zaɓi (“7 + 3” ko “5 + 2” [5 days cytarabine plus 2 days daunorubicin ko idarubicin], bi da bi),
- b) Ƙarfafawa: 35.4 MG na baki sau ɗaya kowace rana a kwanakin 6-19 na cytarabine mai girma (1.5 zuwa 3 g / m2 kowace sa'o'i 12 a ranakun 1, 3 da 5) har zuwa 4 hawan keke, kuma
- c) Kulawa: 26.5 MG na baki sau ɗaya kowace rana akan Ranaku 1 zuwa 14 da 53 MG sau ɗaya kowace rana, bayan haka, har zuwa zagayowar kwanaki talatin da shida na 28.
Duba cikakken bayanin rubutawa na Vanflyta
