基石藥業-B(02616.HK)：胃腸道間質瘤精準靶向藥AYVAKIT®(avapritinib)在中國香港獲批
格隆匯12月28日丨基石藥業-B(02616.HK)發佈公吿，胃腸道間質瘤(“GIST”)同類首創精準靶向藥 AYVAKIT® (avapritinib) 在中國香港的新藥上市申請已獲批准，用於治療攜帶PDGFRA D842V突變無法切除或轉移性胃腸道間質瘤成人患者。該藥物成為中國香港第一個針對攜帶 PDGFRA D842V突變GIST患者的精準靶向藥物。AYVAKIT®是一款強效、高選擇性、口服針對 KIT和PDGFRA突變的抑制劑，由基石藥業合作伙伴Blueprint Medicines Corporation (NASDAQ: BPMC) (“Blueprint Medicines”) 開發。
基石藥業董事長兼首席執行官江甯軍博士表示：“AYVAKIT®是基石藥業在中國香港獲批的首款產品。今年AYVAKIT®已先後在中國大陸和中國台灣獲批上市，我們非常欣喜能夠把這一創新療法帶給更多GIST患者。一直以來，基石藥業致力於為全球患者帶來高品質的創新藥物。未來，我們也將不斷努力，加速研發創新藥物，以滿足更多癌症患者的未盡之需。”
此次AYVAKIT®獲得中國衞生署的批准是基於NAVIGATOR研究，該研究是一項開放標籤、劑量遞增/劑量擴展的Ⅰ期研究，評估AYVAKIT®用於不可切除或轉移性GIST患者的安全性和療效。 2020年12月《歐洲癌症雜誌》(European Journal of Cancer，EJC )全文發表了NAVIGATOR研究針對PDGFRA D842V突變GIST患者的更新數據，38例起始劑量為300/400mg的患者中，36例緩解， ORR高達95%。28例起始劑量為300mg的患者中，27例緩解，ORR為96%，所有劑量組的疾病控制率(DCR)高達100%。所有劑量組的中位DOR長達27.6個月。最常見的治療相關不良事件(AE) 是貧血、膽紅素增高、白細胞下降、肌酸磷酸激酶增加、天冬氨酸轉氨酶增加、面部水腫、眶周水腫、中性粒計數下降、髮色改變等。再次夯實了阿伐替尼的穩健、持久、高效的臨牀獲益，且安全性可控。
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