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基石药业(02616.HK)合作伙伴Blueprint Medicines收到CHMP积极审查意见
格隆汇 08-05 08:34

格隆汇 8 月 5日丨基石药业-B(02616.HK)发布公告,公司的合作伙伴 Blueprint Medicines Corporation(纳斯达克股份代号:BPMC)于2020年7月24日宣布,欧洲药品管理局人用医药产品委员会(“CHMP”)发布一份积极审查意见,建议有条件批准avapritinib上市,作为一种单药疗法,用于治疗携带血小板衍生生长因数受体α(“PDGFRA”)D842V突变的不可切除性或转移性胃肠道间质瘤(“GIST”)成人患者。

CHMP的审查意见将提交给负责医药产品上市许可审批的欧盟委员会做进一步审核。针对avapritinib的上市申请,预计欧盟委员会将在今年九月底前作出最终批复。如果获批,avapritinib将成为在欧盟上市的第一款针对携带PDGFRA  D842V突变GIST患者的靶向治疗药物,该药上市销售所用的商品名为AYVAKYT®。

CHMP是基于NAVIGATOR一期临床试验的疗效、安全性资料,以及VOYAGER三期临床试验安全性结果,对avapritinib作出积极审批意见。资料显示,avapritinib在治疗PDGFRA  D842V突变型GIST患者方面表现出深度、持久的临床应答,且耐受性良好。相关临床研究资料已发表在2020年6月29日的“柳叶刀肿瘤学”杂志上。

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