中国国家药品监督管理局将优先审查Pamiparib的新药申请

2020-07-28 Allan MedSci原创

百济神州今日宣布,中国国家药品监督管理局(NMPA)药品评估中心(CDE)已授予Pamiparib新药审查优先权。

百济神州今日宣布,中国国家药品监督管理局(NMPA)药品评估中心(CDE)已授予Pamiparib新药审查优先权。Pamiparib是靶向PARP1和PARP2的研究抑制剂,用于治疗BRCA突变的晚期卵巢癌、输卵管癌或原发性腹膜癌的患者,这些患者已经接受了两种或两种以上的化学疗法。

百济神州免疫肿瘤学首席医学官Yong Ben博士称:“我们期待在即将举行的医学会议上展示Pamiparib的临床数据”。I/II期临床试验的关键II期部分(NCT03333915)取得了积极结果,该研究招募了至少113例经过两次以上标准化疗的晚期上皮性卵巢癌(包括输卵管癌或原发性腹膜癌)或晚期子宫内膜样上皮癌的中国患者。

尽管从字面上看,BRCA全称——BReast CAncer susceptibility gene——是乳腺癌易感基因,但是BRCA基因突变与遗传性卵巢癌(hereditary ovarian cancer)也有关联。

 

原始出处:

https://www.firstwordpharma.com/node/1743782?tsid=4

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