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首页> 美国卫生研究院文献>The Oncologist >U.S. Food and Drug Administration Approval Summary: Ramucirumab for the Treatment of Metastatic Non-Small Cell Lung Cancer Following Disease Progression On or After Platinum-Based Chemotherapy
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U.S. Food and Drug Administration Approval Summary: Ramucirumab for the Treatment of Metastatic Non-Small Cell Lung Cancer Following Disease Progression On or After Platinum-Based Chemotherapy

机译：美国食品和药物管理局批准摘要：雷米珠单抗用于治疗转移性非小细胞肺癌铂类化学疗法治疗后或疾病发展后

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On December 12, 2014, the U.S. Food and Drug Administration (FDA) approved ramucirumab for use in combination with docetaxel for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving ramucirumab. This approval was based on an improvement in overall survival (OS) with an acceptable toxicity profile in a randomized, multicenter, double-blinded, placebo-controlled trial of 1,253 patients with metastatic NSCLC previously treated with a platinum-based combination therapy. Patients were randomized 1:1 to receive either ramucirumab in combination with docetaxel or placebo in combination with docetaxel. The primary endpoint was OS. Patients who received ramucirumab in combination with docetaxel had improved OS (hazard ratio [HR]: 0.86; 95% confidence interval [CI]: 0.75, 0.98). Median OS was 10.5 months on the ramucirumab plus docetaxel arm versus 9.1 months on the placebo plus docetaxel arm. The most frequent (≥30%) adverse reactions in ramucirumab-treated patients were fatigue, neutropenia, and diarrhea. The most frequent (≥5%) grade 3 and 4 adverse reactions in the ramucirumab arm were fatigue, neutropenia, febrile neutropenia, leukopenia, and hypertension.
机译：2014年12月12日，美国食品药品监督管理局（FDA）批准将拉莫西鲁单抗与多西他赛联用，用于治疗铂类化学疗法或其后疾病进展的转移性非小细胞肺癌（NSCLC）患者。具有表皮生长因子受体或间变性淋巴瘤激酶基因组肿瘤异常的患者，在接受雷莫昔单抗治疗之前，应先通过FDA批准的这些异常进行疾病进展。这项批准是基于一项随机，多中心，双盲，安慰剂对照试验中1,253名先前接受过铂类联合治疗的转移性NSCLC患者的总体生存率（OS）的改善和可接受的毒性。患者以1：1的比例随机接受雷莫西单抗联合多西他赛或安慰剂联合多西他赛。主要终点是操作系统。接受雷莫昔单抗联合多西他赛治疗的患者的OS改善（危险比[HR]：0.86； 95％置信区间[CI]：0.75、0.98）。雷莫昔单抗联合多西他赛组的中位OS为10.5个月，而安慰剂联合多西他赛组的中位OS为9.1个月。在接受拉莫西鲁单抗治疗的患者中，最常见的不良反应（≥30％）是疲劳，中性粒细胞减少和腹泻。拉莫西鲁布组中最常见的（≥5％）3级和4级不良反应是疲劳，中性粒细胞减少，高热性中性粒细胞减少，白细胞减少和高血压。

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