默沙东的PARP抑制剂Lynparza治疗卵巢癌获美国优先审查

2020-01-16 不详 MedSci原创

默沙东宣布已向FDA成功完成PARP抑制剂Lynparza(olaparib)的补充新药申请,并被授予优先审查,与贝伐单抗(Genentech出售,阿瓦斯汀(Avastin))用于晚期卵巢癌。

默沙东宣布已向FDA成功完成PARP抑制剂Lynparza(olaparib)的补充新药申请,并被授予优先审查,与贝伐单抗(Genentech出售,阿瓦斯汀(Avastin))用于晚期卵巢癌

该公司表示,优先审查是基于关键的III期PAOLA-1试验结果,该药物组合将疾病进展或死亡的风险降低了41%,并改善了无进展生存期(PFS)的中位数至22.1个月,而贝伐单抗组的中位数为16.6个月。

此外,在开始试验的两年后,该双盲III期试验发现,使用该组合治疗的患者中46%没有表现出疾病进展,而单独使用贝伐单抗治疗的患者中这一比例为28%。

该PARP抑制剂最近在美国也被批准作为BRCA突变的转移性胰腺癌的一线维持治疗药物,使其成为首个在胰腺癌中获批的该类产品。

Lynparza正在各种PARP依赖性肿瘤中进行测试,这些类型的肿瘤在DDR通路中存在缺陷和依赖性。

卵巢癌是全球女性死于癌症的第八大普遍原因,2018年诊断出近300000例新病例,约有185000例死亡。大多数女性被诊断出患有晚期(III期或IV期)卵巢癌,并且5年生存率约为30%。

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    2020-08-10 jklm09
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    2020-01-18 yese
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    2020-01-18 zhaojie88
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    2020-01-16 一个字-牛

    学习了谢谢分享

    0

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