Jan 2023: Adagrasib (Krazati, Mirati Therapeutics, Inc.), mai hana RAS GTPase iyali, an ba da izini ta hanzari ta Cibiyar Abinci da Magunguna (FDA) don manya marasa lafiya tare da KRAS G12C-mutated na gida ko ciwon daji marasa ƙananan ƙwayoyin cuta (NSCLC), kamar yadda gwajin da aka amince da FDA ya gano. , waɗanda suka karɓi aƙalla tsarin tsarin tsarin gaba ɗaya.
A matsayin ƙarin bincike na abokin tarayya don Krazati, FDA ta kuma amince da QIAGEN therascreen KRAS RGQ PCR kit (nama) da Agilent Resolution ctDx FIRST Assay (plasma). Ya kamata a bincika ƙwayar ƙwayar cuta idan babu alamar maye gurbi a cikin samfurin plasma.
The KRYSTAL-1 gwajin gwaji (NCT03785249), which involved patients with locally advanced or metastatic NSCLC with KRAS G12C mutations, served as the foundation for the approval. Efficacy was assessed in 112 individuals whose illness had advanced during or after receiving immune checkpoint inhibitors and platinum-based chemotherapy, either concurrently or sequentially. Patients got adagrasib 600 mg twice daily until their condition progressed or the side effects became intolerable.
Ma'aunin sakamako na farko shine tsawon lokacin amsawa da kuma tabbatar da ƙimar amsawar haƙiƙa (ORR) daidai da RECIST 1.1, kamar yadda nazari na tsakiya mai zaman kansa (DOR) ya tantance. Matsakaicin DOR shine watanni 8.5 (95% CI: 6.2, 13.8), kuma ORR shine 43% (95% CI: 34%, 53%).
Zawo, tashin zuciya, gajiya, amai, ciwon musculoskeletal, hepatotoxicity, nakasar koda, dyspnea, edoema, rage cin abinci, tari, ciwon huhu, rashin fahimta, maƙarƙashiya, ciwon ciki, da tsawaita tazara ta QTc sune mafi yawan sakamako masu illa (20%). Rage lymphocytes, ƙara aspartate aminotransferase, ƙara sodium, rage sodium, rage haemoglobin, ƙara creatinine, rage albumin, ƙara alanine aminotransferase, ƙara lipase, rage platelet, rage magnesium, rage potassium su ne mafi m dakin gwaje-gwaje naka (25%).
Adagrasib Ya kamata a sha allunan baki da baki sau biyu a rana a kashi na 600 MG har sai yanayin ya ci gaba ko kuma akwai guba maras iya jurewa.
