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FDA批准Ramucirumab用于非小细胞肺癌治疗

2014-12-15 MedSci MedSci原创

美国食品和药物监督管理局(FDA)今天扩大了ramucirumab(Cyramza Eli Lilly)的适应症,包括治疗转移性的非小细胞肺癌(NSCLC)。 今年早些时候,该药物被批准用于治疗胃癌,作为单药治疗或者联用紫杉醇。Ramucirumab是完全人类单克隆抗体用于治疗实体肿瘤。它是血管内皮生长因子受体2(VEGFR)拮抗剂,特异性的键合、阻止受体活化。 “今天是ramucirumab

美国食品和药物监督管理局(FDA)今天扩大了ramucirumab(Cyramza Eli Lilly)的适应症,包括治疗转移性的非小细胞肺癌(NSCLC)。

今年早些时候,该药物被批准用于治疗胃癌,作为单药治疗或者联用紫杉醇。Ramucirumab是完全人类单克隆抗体用于治疗实体肿瘤。它是血管内皮生长因子受体2(VEGFR)拮抗剂,特异性的键合、阻止受体活化。

“今天是ramucirumab2014年已经收到的批准的第三个适应症,”FDA药物评价和研究中心在一份声明中,血液学和肿瘤产品医学办公室主任Richard Pazdur说。“致力于研究ramucirumab在多种恶性肿瘤患者治疗方案为病人提供重要选择。”

批准是基于三期临床研究,一项来自六大洲的26个国家的1253名非鳞状细胞和鳞状细胞的非小细胞肺癌患者的国际研究(Lancet. 2014;384:665-673)。在非小细胞肺癌局部晚期或转移性疾病的患者经过铂化疗治疗后的疾病阶段,通过对比ramucirumab加多西他赛与安慰剂加多西他赛的研究。发现ramucirumab比安慰剂组的总生存期多了1.4个月。中位总生存期ramucirumab组比安慰剂组要更好(10.5 vs 9.1个月;危险比[HR],0.857;P = .0235),平均无进展生存期(4.5 vs 3.0个月;危险比,0.762;P <.0001)。整体响应率ramucirumab组也更好的(23% vs 14%;P <.0001)。总的来说,这些结果对于治疗肺癌的患者来说是非常令人鼓舞。


根据生产厂商,ramucirumab比安慰剂组出现的频繁地最常见的3级和更高的不良反应事件,有中性粒细胞减少(48.8% vs 39.8%),发热性中性粒细胞减少(15.9% vs 10.0%),疲劳(14.0% vs 10.5%),白细胞减少(13.7% vs 12.5%)和高血压(5.6% vs 2.1%)。5级的不良反应事件两组分别为(5.4% vs 5.8%)。ramucirumab组患者出现更多的流血/出血事件相比于比安慰剂组(28.9% vs 15.2%),但3级或更高的流血/出血事件在两组中是相似的(2.4% vs 2.3%)。

在FDA的优先审查程序下,这个新适应症的应用得到审查,它们加快审查的药物是用于治疗严重疾病或若得到批准,与现有市场上产品相比将有显著改善的症状。

原始出处

Roxanne Nelson. FDA Approves Ramucirumab for Non-small Cell Lung Cancer. December 12, 2014.

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    2015-03-27 bugit
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    2015-04-06 snf701207
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    2014-12-16 cbp

    致力于研究ramucirumab在多种恶性肿瘤患者治疗方案为病人提供重要选择

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