基石藥業(02616.HK)合作伙伴Blueprint Medicines收到CHMP積極審查意見
格隆匯 8 月 5日丨基石藥業-B(02616.HK)發佈公告,公司的合作伙伴 Blueprint Medicines Corporation(納斯達克股份代號:BPMC)於2020年7月24日宣佈,歐洲藥品管理局人用醫藥產品委員會(“CHMP”)發佈一份積極審查意見,建議有條件批准avapritinib上市,作為一種單藥療法,用於治療攜帶血小板衍生生長因數受體α(“PDGFRA”)D842V突變的不可切除性或轉移性胃腸道間質瘤(“GIST”)成人患者。
CHMP的審查意見將提交給負責醫藥產品上市許可審批的歐盟委員會做進一步審核。針對avapritinib的上市申請,預計歐盟委員會將在今年九月底前作出最終批覆。如果獲批,avapritinib將成為在歐盟上市的第一款針對攜帶PDGFRA D842V突變GIST患者的靶向治療藥物,該藥上市銷售所用的商品名為AYVAKYT®。
CHMP是基於NAVIGATOR一期臨牀試驗的療效、安全性資料,以及VOYAGER三期臨牀試驗安全性結果,對avapritinib作出積極審批意見。資料顯示,avapritinib在治療PDGFRA D842V突變型GIST患者方面表現出深度、持久的臨牀應答,且耐受性良好。相關臨牀研究資料已發表在2020年6月29日的“柳葉刀腫瘤學”雜誌上。
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