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Drugs. 2021 Sep;81(13):1573-1579. doi: 10.1007/s40265-021-01574-2.
Sotorasib (LUMAKRAS) is a RAS GTPase family inhibitor being developed by Amgen for the treatment of solid tumours with KRAS mutations, including non-small cell lung cancer (NSCLC) and colorectal cancer. In May 2021, sotorasib was granted accelerated approval by the US FDA for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. This article summarizes the milestones in the development of sotorasib leading to this first approval for KRAS G12C-mutated NSCLC.
索托拉西布（LUMAKRAS）是一种 RAS GTP 酶家族抑制剂，由安进公司开发，用于治疗具有 KRAS 突变的实体瘤，包括非小细胞肺癌（NSCLC）和结直肠癌。2021 年 5 月，索托拉西布获得美国食品药品监督管理局（FDA）的加速批准，用于治疗经 FDA 批准的检测方法确定的携带 KRAS G12C 突变的局部晚期或转移性 NSCLC 成年患者，这些患者至少接受过一次系统治疗。本文总结了索托拉西布的开发里程碑，这些里程碑促成了其对 KRAS G12C 突变 NSCLC 的首次批准。
