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LYNPARZA(olaparib)联合贝伐单抗一线治疗HRD阳性晚期卵巢癌:已获FDA首肯

2020-05-11 Allan MedSci原创

阿斯利康(AstraZeneca)和默克(Merck)今日宣布,美国食品药品监督管理局(FDA)已批准LYNPARZA(olaparib)联合贝伐单抗一线维持治疗晚期上皮性卵巢癌。

阿斯利康(AstraZeneca)和默克(Merck)今日宣布,美国食品药品监督管理局(FDA)已批准LYNPARZA(olaparib)联合贝伐单抗一线维持治疗晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌,这些患者对一线铂类化学疗法有完全或部分反应,且BRCA基因为同源重组缺陷(HRD)阳性状态。

这项批准是基于PAOLA-1 III期试验的387例HRD阳性肿瘤患者的数据分析,该研究表明LYNPARZA联合贝伐单抗可将疾病进展或死亡的风险降低67%(HR 0.33,95%CI 0.25-0.45)。对于HRD阳性的晚期卵巢癌患者,联合治疗将中位无进展生存期(PFS)提高到37.2个月,而单独使用贝伐单抗仅提高到17.7个月。

然而,与单独使用贝伐单抗的患者相比,接受LYNPARZA联合贝伐单抗的患者发生静脉血栓栓塞的可能性更高(5.0%比1.9%)。LYNPARZA联合贝伐单抗组中有54%的患者中断剂量,41%的患者降低剂量,20%的患者因不良反应终止治疗。

 

原始出处:

https://www.firstwordpharma.com/node/1722930

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    2020-08-05 刘阔
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    2020-07-17 LSJ122
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