2021 Agustus: FDA masihan persetujuan gancang pikeun sotorasib (LumakrasTM, Amgen, Inc.), a inhibitor kulawarga RAS GTPase, pikeun penderita sawawa kalawan KRAS G12C mutated lokal maju atawa métastatik kanker paru sél non-leutik (NSCLC) anu geus narima sahanteuna hiji terapi sistemik prior, sakumaha ditangtukeun ku tés FDA-disatujuan.
Salaku diagnostik pendamping pikeun Lumakras, FDA parantos nyatujuan kit (jaringan) PCR therascreen® KRAS RGQ QIAGEN sareng Guardant360® CDx (plasma). Jaringan tumor kedah dievaluasi upami henteu aya mutasi dina sampel plasma.
The approval was based on CodeBreaK 100, a multicenter, single-arm, open label clinical study (NCT03600883) that included patients with KRAS G12C mutations who had locally progressed or metastatic NSCLC. The efficacy of the drug was tested in 124 patients whose disease had progressed on or after at least one previous systemic therapy. Sotorasib 960 mg orally once a day was given to patients until disease progression or intolerable toxicity.
Hasil efektivitas primér nya éta laju respon obyektif (ORR) nurutkeun RECIST 1.1, sakumaha ditangtukeun ku review sentral bebas buta, sarta panjang respon. Kalayan waktos réspon median 10 bulan (rentang 1.3+, 11.1), ORR éta 36 persén (95 persén CI: 28 persén, 45 persén).
Diare, nyeri muskuloskeletal, seueul, kacapean, hépatotoxicity, sareng batuk mangrupikeun efek samping anu paling umum (20%). Turunna limfosit, turunna hémoglobin, ngaronjat aspartat aminotransferase, ngaronjat alanine aminotransferase, turun kalsium, ngaronjat alkali fosfatase, ngaronjat protéin cikiih, jeung turun natrium mangrupa abnormalitas laboratorium paling umum (25 persen).
Sotorasib dicokot sakali sapoé, kalayan atawa tanpa dahareun, dina dosis 960 mg.
Dosis 960 mg disatujuan dumasar kana bukti klinis anu sayogi ogé simulasi farmakokinetik sareng farmakodinamik anu ngadukung jumlahna. FDA nungtut uji coba postmarketing salaku bagian tina evaluasi pikeun persetujuan gancangan ieu pikeun ningali naha dosis anu langkung handap bakal gaduh pangaruh terapi anu sami.
Rujukan: https://www.fda.gov/
Pariksa rinci Ieuh.
