Jan 2023: Adagrasib (Krazati, Mirati Therapeutics, Inc.), inhibitor kulawarga RAS GTPase, dibéré persetujuan gancangan ku Administrasi Pangan sarta Narkoba (FDA) pikeun penderita sawawa kalawan KRAS G12C-mutated lokal maju atawa kanker paru sél non-leutik métastatik (NSCLC), sakumaha dicirikeun ku uji FDA-disatujuan. , anu geus narima sahanteuna hiji terapi sistemik prior.
Salaku diagnostik pendamping tambahan pikeun Krazati, FDA ogé nyatujuan kit (jaringan) layar layar QIAGEN KRAS RGQ PCR sareng Agilent Resolution ctDx FIRST Assay (plasma). Jaringan tumor kedah ditaliti upami teu aya indikasi mutasi dina sampel plasma.
The KRYSTAL-1 sidang klinis (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.
Ukuran hasilna efficacy primér éta lilana respon sarta dikonfirmasi laju respon obyektif (ORR) luyu jeung RECIST 1.1, sakumaha ditaksir ku review sentral bebas buta (DOR). DOR median nyaéta 8.5 bulan (95% CI: 6.2, 13.8), sareng ORR nyaéta 43% (95% CI: 34%, 53%).
Diare, seueul, kacapean, utah, nyeri muskuloskeletal, hépatotoxicity, gangguan ginjal, dyspnea, edema, turun napsu, batuk, pneumonia, disorientasi, kabebeng, nyeri beuteung, sareng perpanjangan interval QTc mangrupikeun efek samping anu paling sering (20%). Ngurangan limfosit, ngaronjat aspartat aminotransferase, ngaronjat natrium, turun natrium, turun hémoglobin, ngaronjat kréatinin, turun albumin, ngaronjat alanin aminotransferase, ngaronjat lipase, turun trombosit, turun magnésium, jeung kalium turunna mangrupa abnormalitas laboratorium paling umum (25%).
Adagrasib Tablet kedah dicandak sacara lisan dua kali dinten dina dosis 600 mg dugi ka kaayaan maju atanapi aya karacunan anu teu kaampeuh.
