罗氏Xofluza作为预防性流感药物III期临床安全有效

2019-09-02 不详 MedSci原创

罗氏宣布在III期临床BLOCKSTONE研究中,与使用安慰剂相比,接触感染家庭成员后使用Xofluza(baloxavir marboxil)进行预防性治疗,患流感的风险显着降低了86%。

罗氏宣布在III期临床BLOCKSTONE研究中,与使用安慰剂相比,接触感染家庭成员后使用Xofluza(baloxavir marboxil)进行预防性治疗,患流感的风险显着降低了86%。

结果显示,只有1.9%的Xofluza治疗家庭成员患有流感,而安慰剂治疗组有13.6%,与安慰剂相比,这一益处仍具有统计学意义。而安慰剂组,家庭接触者中观察到的流感相关并发症风险较高(2.2%对15.4%),12岁以下的儿童更容易患流感(4.2%对15.5%)。

该公司还宣布该药具有与安慰剂相当的安全性,Xofluza的总不良事件发生率为22.2%,安慰剂为20.5%。

此外,该研究还表明,即使采用较少的流感标准,使用Xofluza与安慰剂相比,家庭成员患流感的风险仍显着降低76%(5.3%对22.4%)。

Xofluza是近20年来FDA批准的第一种具有新型作用机制的流感药物。该药是一种内切核酸酶抑制剂,旨在抑制流感病毒中的CAP帽子结构依赖性内切核酸酶,该酶对于流感病毒的复制必不可少。

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    2020-08-11 juliusluan78
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罗氏Genentech宣布,FDA批准其ALK 抑制剂Rozlytrek(entrectinib),用于治疗12岁以上、无治疗方法、NTRK基因融合的实体肿瘤儿童和成人患者。该机构还批准Rozlytrek治疗ROS1阳性的转移性非小细胞肺癌(NSCLC)成人患者。

罗氏以43亿美元收购基因治疗公司Spark Therapeutics

罗氏以每股114.50美元,总计43亿美元现金收购基因疗法公司Spark Therapeutics,该交易预计将在第二季度完成。

FDA加速批准第三款“不限癌种”疗法

8月15日,FDA加速批准罗氏Rozlytrek(Entrectinib,恩曲替尼)上市,用于治疗神经营养性酪氨酸受体激酶(NTRK)基因融合阳性的晚期复发实体瘤成人和儿童患者。同时,FDA还批准Rozlytrek用于治疗携带ROS1基因突变的转移性非小细胞肺癌。这是继Keytruda和Vitrakvi之后,FDA批准的第三款“不限癌种”的抗癌疗法。

罗氏的PD-L1单抗Tecentriq 治疗三阴性乳腺癌即将获得FDA批准

罗氏的PD-L1单抗Tecentriq(atezolizumab)与化疗药(Abraxane,nab-paclitaxel)联合,用于PD-L1阳性的、无法切除的局部晚期或转移性三阴性乳腺癌(TNBC)患者,通过了FDA的批准测试。