Agusta 2021: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) Cibiyar Abinci da Magunguna ta ba da izini ga manya marasa lafiya tare da rashin daidaituwa na gyare-gyare (dMMR) mai maimaitawa ko ci gaba da ciwace-ciwacen ciwace-ciwace, kamar yadda gwajin da FDA ta amince da shi, wanda ya ci gaba akan ko bin magani na farko kuma waɗanda basu da gamsasshen madadin magani. zažužžukan.
Kwamitin VENTANA MMR RxDx shi ma FDA ta ba da izini a yau a matsayin na'urar bincike ta abokin tarayya ga marasa lafiya tare da ciwace-ciwacen ciwace-ciwacen ƙwayoyi na dMMR waɗanda ake yi musu magani da dostarlimab-gxly.
Gwajin GARNET (NCT02715284), wanda ba bazuwar, cibiyar sadarwa, buɗaɗɗen lakabin, gwaji da yawa, ya kalli ingancin dostarlimab. Yawan tasiri ya haɗa da marasa lafiya 209 tare da ciwace-ciwacen ciwace-ciwacen ƙwayar cuta na dMMR ko ci gaba waɗanda suka ci gaba bayan jiyya na tsarin kuma basu da wasu zaɓuɓɓuka.
Yawan amsa gabaɗaya (ORR) da tsawon lokacin amsawa (DoR) sune manyan sakamako masu inganci, kamar yadda aka kafa ta hanyar nazari na tsakiya mai zaman kansa mai zaman kansa daidai da RECIST 1.1. Tare da cikakkiyar ƙimar amsawar kashi 9.1 da kashi 32.5 cikin ɗari na juzu'i, ORR ya kasance kashi 41.6 cikin ɗari (95 bisa dari CI: 34.9, 48.6). Matsakaicin DOR shine watanni 34.7 (kewaye 2.6 zuwa 35.8+), kuma kashi 95.4 na marasa lafiya suna da DOR na ƙasa da watanni 6.
Gajiya/asthenia, anemia, gudawa, da tashin zuciya sune mafi girman martanin gefe a cikin mutanen da ke da ɗimbin ciwace-ciwace na dMMR (kashi 20). Anemia, gajiya / asthenia, haɓakar transaminases, sepsis, da mummunan rauni na koda sune mafi yawan abubuwan da suka faru na Grade 3 ko 4 (2%). Pneumonitis, colitis, hepatitis, endocrinopathy, nephritis, da dermatologic toxicity duk abubuwan da ba su dace ba ne na rigakafi da ke hade da dostarlimab-gxly.
Ana ba da Dostarlimab azaman jiko na cikin jini sama da mintuna 30 kowane mako uku don allurai ɗaya zuwa huɗu. Ana ƙara yawan adadin zuwa 1,000 MG kowane mako 6 yana farawa makonni 3 bayan kashi 4.
reference: https://www.fda.gov/
Duba cikakkun bayanai nan.
