Fabrairu 2023: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) An ba da izinin FDA don kula da tsofaffi marasa lafiya da rashin daidaituwa na gyaran gyare-gyare (dMMR) mai maimaitawa ko ci gaba da ciwon daji na endometrial wanda ya ci gaba a lokacin ko bayan tsarin da ya ƙunshi platinum a kowane wuri kuma waɗanda ba 'yan takara ba ne don tiyata ko radiation, kamar yadda ya ƙaddara. Gwajin da FDA ta amince.
Dostarlimab-gxly ya sami karbuwa cikin hanzari a cikin Afrilu 2021 don manya marasa lafiya da ke da maimaitawar dMMR ko ciwon daji na endometrial wanda ya ci gaba a lokacin ko bayan maganin da ke ɗauke da platinum na baya, kamar yadda gwajin da FDA ta amince da shi ya ƙaddara.
GARNET (NCT02715284), multicenter, multicohort, gwajin alamar buɗaɗɗen da aka yi a cikin marasa lafiya tare da ci-gaban ciwace-ciwacen ciwace-ciwace, an gwada inganci don daidaitaccen yarda. Ƙungiyar marasa lafiya 141 tare da dMMR mai maimaitawa ko ci gaba da ciwon daji na endometrial wanda ya ci gaba a lokacin ko bayan karbar magani mai dauke da platinum ya ƙunshi yawan tasiri. Marasa lafiya waɗanda kwanan nan suka karɓi magungunan rigakafi na tsarin rigakafi don cututtukan autoimmune ko waɗanda a baya sun karɓi PD-1/PD-LI-blocking antibodies ko wasu masu hana wuraren bincike na rigakafi an cire su.
Yawan amsa gabaɗaya (ORR) da tsawon lokacin amsawa (DOR), kamar yadda aka ƙaddara ta hanyar nazari na tsakiya mai zaman kansa mai zaman kansa bisa ga RECIST v1.1, sune mahimman matakan sakamako na inganci. Tabbatar da ORR shine 45.4% (95% CI: 37.0, 54.0), tare da 15.6% na masu amsa suna amsa cikakke kuma 29.8% suna amsawa kaɗan. Tare da 85.9% na marasa lafiya da ke da tsawon lokaci a ƙarƙashin watanni 12 da 54.7% suna da tsawon lokaci a kan watanni 24 (kewaye: 1.2+, 52.8+), matsakaicin DOR bai hadu ba.
The most frequent negative effects (20%) were asthenia/fatigue, anaemia, rash, nausea, diarrhoea, and vomiting. Pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal failure, and skin adverse reactions are examples of immune-mediated adverse reactions that can happen.
Ya kamata a gudanar da allurai 1 zuwa 4 na dostarlimab-gxly a kashi da jadawalin 500 MG kowane mako uku. Magani na gaba shine 1,000 MG kowane mako 6 yana farawa makonni 3 bayan kashi 4, ci gaba har sai cutar ta ci gaba ko kuma akwai cutar da ba za a iya jurewa ba. Dole ne a ba da Dostarlimab-gxly ta cikin jini a cikin minti 30.
Duba cikakken bayanin rubutawa na Jemperli.
