Nuwamba 2022: Ga manya marasa lafiya waɗanda suka sami tsarin tsarin jiyya ɗaya zuwa uku da suka gabata kuma suna da folate receptor alpha (FR) tabbatacce, platinum-resistant epithelial ovarian, tube fallopian, ko ciwon daji na peritoneal na farko, Hukumar Abinci da Magunguna ta ba da izini ga mirvetuximab soravtansine- gynx (Elahere, ImmunoGen, Inc.). An haɗa mai hanawa microtubule da folate receptor alpha directed antibody a cikin mirvetuximab soravtansine-gynx. Ana amfani da gwajin da FDA ta amince da shi don sanin ko waɗanne marasa lafiya za su karɓi magani.
VENTANA FOLR1 (FOLR-2.1) RxDx Assay (Ventana Medical Systems, Inc.) an ba shi izinin FDA kawai a matsayin kayan aikin bincike na abokin don alamar da aka ambata.
Nazarin 0417 (NCT04296890), gwajin hannu guda ɗaya wanda ya ƙunshi marasa lafiya 106 tare da FR-positive, platinum-resistant epithelial ovarian, tube fallopian, ko ciwon daji na peritoneal na farko, ya kimanta tasirin magani. Har zuwa layukan da suka gabata guda uku na tsarin jiyya an ba da izini ga marasa lafiya. Bevacizumab ya kasance buƙata ga duk marasa lafiya. Marasa lafiya waɗanda ciwace-ciwacen daji suka gwada tabbatacce don maganganun FR ta amfani da ƙimar da aka ambata a baya an haɗa su cikin binciken. An hana marasa lafiya idan suna da cututtukan huhu marasa kamuwa da cuta, Grade> 1 peripheral neuropathy, matsalolin corneal, ko cututtukan ido waɗanda ke buƙatar ci gaba da kulawa.
Marasa lafiya sun sami jiko na intravenous na mirvetuximab soravtansine-gynx 6 mg/kg (dangane da daidaitaccen nauyin jiki mai kyau) kowane mako uku har sai yanayin su ya ci gaba ko kuma tasirin sakamako ya zama mara haƙuri. Kowane mako shida a cikin makonni 36 na farko, sannan kuma kowane mako 12 bayan haka, an gudanar da kimantawar martanin ƙari.
Yawan amsa gabaɗaya (ORR) da tsawon lokacin amsawa (DOR) kamar yadda mai binciken ya ƙaddara kuma aka auna daidai da sigar RECIST 1.1 sune matakan sakamako na farko na inganci. ORR da aka tabbatar shine 31.7% (95% CI: 22.9, 41.6) kuma DOR na tsakiya shine watanni 6.9 (95% CI: 5.6, 9.7) a cikin ingantaccen samfurin marasa lafiya waɗanda ke da juriya na platinum, rashin lafiya mai ƙididdigewa kuma sun karɓi aƙalla ɗaya. kashi (104 marasa lafiya).
Rage hangen nesa, gajiya, ƙara aspartate aminotransferase, tashin zuciya, ƙara alanine aminotransferase, keratopathy, ciwon ciki, rage lymphocytes, peripheral neuropathy, zawo, rage albumin, maƙarƙashiya, ƙara alkaline phosphatase, bushe ido, rage magnesium, rage leukocytes, rage neutrophils. raguwar haemoglobin sune mafi yawan halayen halayen (20%), gami da rashin daidaituwa na dakin gwaje-gwaje. Akwai gargadin akwati don gubar ido akan alamar samfur.
Adadin da aka ba da shawarar na mirvetuximab soravtansine-gynx shine 6 mg/kg wanda aka daidaita daidaitaccen nauyin jiki (AIBW), ana ba da shi ta hanyar jini sau ɗaya a kowace kwanaki 21 (zagayowar) har sai cutar ta ci gaba ko rashin haƙuri.
Duba cikakken bayanin rubutawa don Elahere.
