基石藥業-B(02616.HK)：艾伏尼布新藥上市申請已獲國家藥品監督管理局受理並擬納入優先評審
格隆匯8月3日丨基石藥業-B(02616.HK)發佈公吿，艾伏尼布(TIBSOVO®, ivosidenib片劑)在中國的註冊研究CS3010-101研究達到預期終點，在攜帶易感異檸檬酸脱氫酶-1(“IDH1”)突變的中國復發或難治性急性髓系白血病(“R/R AML”)患者中，艾伏尼布顯示了明確的療效和可控的安全性，且與之前發佈的全球研究人羣中的療效和安全性數據基本一致。基石藥業計劃在近期召開的國際學術會議上公佈該註冊研究的具體數據。
同時基石藥業宣佈，中國國家藥品監督管理局(“NMPA”)已受理艾伏尼布的新藥上市申請(“NDA”)，用於治療攜帶IDH1易感突變的成人R/R AML患者並擬納入優先評審。
CS3010-101研究主要研究者、中國醫學科學院血液病醫院王建祥教授表示：“在 AML 治療領域，我們正面臨急迫的臨牀治療需求，尤其是對於 IDH1 易感突變的 R/R AML 患者，目前國內尚無靶向治療藥物上市。祝賀艾伏尼布在中國 R/R AML 患者中的註冊研究取得成功，期待其在中國早日獲批上市，為 AML 患者帶來新希望。”
基石藥業首席醫學官楊建新博士表示：“我們高興地看到艾伏尼布治療中國R/RAML患者安全有效。艾伏尼布是基石藥業繼普吉華®、泰吉華®和舒格利單抗後第四個遞交新藥上市申請的創新藥，同時此次NDA的遞交也是基石藥業遞交的第七項NDA/擴展適應症(“sNDA”)申請。我們會與中國NMPA密切協作，期待儘快把這款創新藥帶給中國患者。”
2020年，艾伏尼布被中國NMPA國家藥品審評中心納入“臨牀急需境外新藥名單(第三批)”，獲得快速通道審評審批資格。同時作為全球同類首創的強效、高選擇性口服IDH1抑制劑，艾伏尼布以其明確的臨牀優勢，入選了2020版《CSCO惡性血液病診療指南》。
艾伏尼布是目前唯一一款在美國獲得美國食品藥品監督管理局(“FDA”)批准的針對攜帶IDH1易感突變的AML患者的靶向療法。艾伏尼布在美國被批准用於治療攜帶IDH1易感突變的R/RAML成人患者和新診斷的年齡至少75歲或因其它合併症而無法使用強化化療的攜帶IDH1易感突變的AML成人患者。施維雅公司擁有艾伏尼布在美國地區的商業化權益。
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