百济神州的BTK抑制剂zanubrutinib治疗淋巴瘤,获得了FDA的优先审查

2019-08-26 不详 MedSci原创

百济神州BeiGene的BTK抑制剂zanubrutinib获得了FDA的优先审查,明年2月可能获得批准。这是BeiGene的一个重要里程碑,也是其候选药物首次在美国申请并接受FDA审查。

百济神州BeiGene的BTK抑制剂zanubrutinib获得了FDA的优先审查,明年2月可能获得批准。这是BeiGene的一个重要里程碑,也是其候选药物首次在美国申请并接受FDA审查。

美国监管机构授予zanubrutinib作为套细胞淋巴瘤(MCL)二线治疗的地位,这是一种侵袭性的非霍奇金淋巴瘤,该药物在今年早些时候也取得了突破性进展。

Zanubrutinib治疗瓦尔登斯特氏巨球蛋白血症先前获得了FDA的快速通道状态,目前也用于慢性淋巴细胞白血病(CLL)和小淋巴细胞淋巴瘤(SLL)的后期测试,以及对卵泡淋巴瘤(FL)和边缘区淋巴瘤(MZL)的早期研究。

BeiGene正试图将zanubrutinib定位为AbbVie /强生公司的BTK抑制剂Imbruvica(ibrutinib)的竞争对手,该药已被批准用于治疗多种血液疾病,包括CLL,MCL和WM。

去年在香港证券交易所上市的 BeiGene 公司表示,该药物在效力和选择性方面具有同类最佳水平,并且具有较低的引起脱靶效应的倾向。

除了zanubrutinib之外,BeiGene还开发了PD-1抑制剂tislelizumab,已经在国内申请批准用于治疗经典霍奇金淋巴瘤,以及pamiparib,一种PARP 1/2抑制剂用于治疗卵巢癌

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    2019-08-28 bugit
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    2019-08-28 fengting7

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百济神州(纳斯达克代码:BGNE;香港联交所代码:06160),是一家处于商业阶段的生物医药公司,专注于用于癌症治疗的创新型分子靶向和肿瘤免疫药物的开发和商业化。百济神州今天宣布在美国路易斯安那州新奥尔良市举行的第二十三届美国神经肿瘤学会年会及教育日上公布其在研PARP抑制剂pamiparib联合放疗(RT)及/或替莫唑胺(temozolomide,TMZ)治疗新诊断或复发/难治性(R/R)多