Agusta 2021: FDA ta ba da izinin hanzarta zuwa sotorasib (LumakrasTM, Amgen, Inc.), mai hana RAS GTPase iyali, don manya marasa lafiya tare da KRAS G12C da aka canza a cikin gida ko kuma ciwon daji marasa ƙananan ƙwayoyin cuta (NSCLC) waɗanda suka sami aƙalla magani na tsarin gaba ɗaya, kamar yadda gwajin da FDA ta amince.
A matsayin abokin bincike don Lumakras, FDA ta amince da QIAGEN therascreen® KRAS RGQ PCR kit (nama) da Guardant360® CDx (plasma). Ya kamata a tantance ƙwayar ƙwayar cuta idan ba a sami maye gurbi a cikin samfurin plasma ba.
Amincewar ta dogara ne akan CodeBreaK 100, cibiyar sadarwa mai yawa, hannu-ɗaya, binciken asibiti na buɗaɗɗen lakabi (NCT03600883) wanda ya haɗa da marasa lafiya tare da maye gurbin KRAS G12C waɗanda suka sami ci gaba a cikin gida ko NSCLC mai tsauri. An gwada ingancin maganin a cikin marasa lafiya 124 waɗanda cutar ta ci gaba a kan ko bayan aƙalla tsarin tsarin da ya gabata. Sotorasib 960 MG na baki sau ɗaya a rana an ba wa marasa lafiya har sai cutar ta ci gaba ko rashin haƙuri.
Sakamakon tasiri na farko shine ƙimar amsawar haƙiƙa (ORR) bisa ga RECIST 1.1, kamar yadda aka ƙaddara ta hanyar nazari na tsakiya mai zaman kansa, da tsayin amsawa. Tare da lokacin amsawa na tsaka-tsaki na watanni 10 (kewaye 1.3+, 11.1), ORR ya kasance 36 bisa dari (95 bisa dari CI: 28 bisa dari, 45 bisa dari).
Zawo, ciwon musculoskeletal, tashin zuciya, gajiya, hanta, da tari sune abubuwan da suka fi yawa (20%). Ragewar lymphocytes, rage haemoglobin, ƙara aspartate aminotransferase, ƙara alanine aminotransferase, rage calcium, ƙara alkaline phosphatase, ƙarar fitsari furotin, da rage sodium su ne mafi rinjaye dakin gwaje-gwaje naka (25%).
Ana shan Sotorasib sau ɗaya a rana, tare da ko ba tare da abinci ba, a kashi na 960 MG.
An yarda da kashi na 960 MG bisa la'akari da shaidar asibiti da ake samuwa da kuma pharmacokinetic da pharmacodynamic simulations waɗanda ke goyan bayan adadin. FDA tana buƙatar gwajin tallace-tallace a matsayin wani ɓangare na kimantawa don wannan haɓakar amincewa don ganin ko ƙananan kashi zai sami irin wannan tasirin warkewa.
Magana: https://www.fda.gov/
Duba cikakkun bayanai nan.
