FDA批准Marqibo治疗罕见急性淋巴细胞白血病

2012-08-14 晓静 医学论坛网

  2012年8月9日,美国食品与药物管理局(FDA)通过加速审批程序批准了“孤儿药”Marqibo (硫酸长春新碱脂质体注射液)用于治疗罕见的成人费城染色体阴性(Ph-)的急性淋巴细胞白血病。   Marqibo此次获准用于治疗白血病患者复发2次以上或病情恶化的患者,或在经过2种以上抗白血病药物治疗方案后病情仍有进展的患者。该药主要成分为常用抗肿瘤药长春新碱,由一种类似细胞膜成分的脂质体包裹,

  2012年8月9日,美国食品与药物管理局(FDA)通过加速审批程序批准了“孤儿药”Marqibo (硫酸长春新碱脂质体注射液)用于治疗罕见的成人费城染色体阴性(Ph-)的急性淋巴细胞白血病。

  Marqibo此次获准用于治疗白血病患者复发2次以上或病情恶化的患者,或在经过2种以上抗白血病药物治疗方案后病情仍有进展的患者。该药主要成分为常用抗肿瘤药长春新碱,由一种类似细胞膜成分的脂质体包裹,每周注射一次。

  该药处方信息有一项加框警告:该药必须通过静脉给药,因为其他方式给药可能有致死危险。加框警告还提示,Marqibo有不同的药物推荐剂量,而非只有单一的硫酸长春新碱注射液。为避免用药过量,建议医务人员在用药前检查药物名称和剂量。详情药物标签有所描述。

  新闻链接:FDA approves Marqibo to treat rare type of leukemia



    

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    2012-10-31 bugit
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    2012-08-16 syscxl

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