美国食品和药物管理局批准概要：索托拉西布治疗 KRAS G12C 突变型转移性非小细胞肺癌。
FDA Approval Summary: Sotorasib for KRAS G12C-Mutated Metastatic NSCLC.
机构信息
Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
出版信息
Clin Cancer Res. 2022 Apr 14;28(8):1482-1486. doi: 10.1158/1078-0432.CCR-21-3074.
On May 28, 2021, the FDA granted accelerated approval to sotorasib (Lumakras, Amgen) for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with a Kirsten rat sarcoma proto-oncogene (KRAS) G12C mutation who have received at least one prior systemic therapy. The approval was based on CodeBreaK 100 (Study 20170543), a dose-escalation and dose-expansion trial in patients with an advanced, KRAS G12C-mutated, solid tumor. The overall response rate (ORR) observed in patients with KRAS G12C-mutated NSCLC treated with sotorasib (n = 124) was 36% [95% confidence interval (CI), 28-45]. The median duration of response was 10.0 months (95% CI, 6.9-not estimable). The most common adverse reactions (≥20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. This is the first approval of a targeted therapy for KRAS G12C-mutated NSCLC. Because of pharmacokinetic data and ORRs of patient cohorts who took sotorasib at lower doses in the dose-escalation portion of CodeBreaK 100, a dose comparison study is being conducted as a post-marketing requirement.
2021 年 5 月 28 日，美国食品药品监督管理局（FDA）加速批准索托拉西布（Lumakras，安进公司）用于治疗接受过至少一种既往系统治疗的携带 Kirsten 大鼠肉瘤原癌基因（KRAS）G12C 突变的晚期非小细胞肺癌（NSCLC）成人患者。此次批准基于 CodeBreaK 100（研究 20170543），这是一项针对晚期、KRAS G12C 突变的实体瘤患者进行的剂量递增和扩展试验。在接受索托拉西布治疗的 KRAS G12C 突变 NSCLC 患者（n=124）中观察到的总体缓解率（ORR）为 36%[95%置信区间（CI），28-45]。缓解持续时间的中位数为 10.0 个月（95%CI，6.9-不可估计）。最常见的不良反应（≥20%）为腹泻、肌肉骨骼疼痛、恶心、疲劳、肝毒性和咳嗽。这是首个针对 KRAS G12C 突变 NSCLC 的靶向治疗药物的批准。由于在 CodeBreaK 100 的剂量递增部分接受较低剂量索托拉西布的患者队列的药代动力学数据和 ORR，正在进行一项剂量比较研究作为上市后要求。
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