基石藥業(02616.HK)胃腸道間質瘤精準靶向藥泰時維®(阿伐替尼片)在中國台灣獲批
近日，台灣地區食品藥物管理署已批准胃腸道間質瘤(GIST)精準靶向藥物泰時維®(阿伐替尼片)的新藥上市申請，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。該藥物成為中國台灣首個針對攜帶PDGFRA D842V突變GIST患者的靶向藥物。
資料顯示，GIST是發生於胃腸道的肉瘤，肉瘤是發生在骨內或源自結締組織的腫瘤。胃腸道間質瘤起源於胃腸道壁中的細胞，並且最常發生在胃或小腸中。大多數患者的確診年齡在50至80歲之間，通常在胃腸道出血、做手術或醫學影像檢查時發現，極少在腫瘤破裂或胃腸道發生梗阻後確診。原發GIST中，約有5％至6％的病例由PDGFRA D842V突變導致，這種突變是最常見的PDGFRA外顯子18突變。
據瞭解，泰時維®獲批是基於全球NAVIGATOR一期臨牀研究結果。2020年歐洲醫學腫瘤學會(ESMO)虛擬大會上公佈了NAVIGATOR研究PDGFRA D842V突變GIST患者數據。截至2020年3月9日數據截止日的結果顯示，在先前接受過或未接受過治療的PDGFRA D842V突變GIST的38例患者中，他們每天接受300或400毫克的阿伐替尼治療。阿伐替尼治療表現出深度、持久的臨牀應答，客觀緩解率為95%(95% CI:82-99%)、中位緩解持續時間為22個月(95%CI：14個月，尚未達到)，並且總體耐受性良好。在服用阿伐替尼所有劑量的250例晚期GIST患者中，最常見的不良事件(≥30％)為噁心，疲勞，貧血，腹瀉，眼眶水腫，嘔吐，食慾下降，流淚增加，記憶力減退和周圍性水腫。
阿伐替尼由基石藥業合作伙伴Blueprint Medicines公司開發。基石藥業與Blueprint Medicines公司達成獨家合作和授權協議，獲得了包括阿伐替尼在內的多款藥物在中國大陸及港澳台地區的獨家開發和商業化授權。今年3月，阿伐替尼已獲中國國家藥品監督管理局已批准，用於治療攜帶PDGFRA外顯子18突變(包括PDGFRA D842V突變)的不可切除性或轉移性GIST成人患者。
全球範圍內，阿伐替尼治療晚期和惰性系統性肥大細胞增生症(SM)患者的臨牀開發正在進行。美國FDA已授予阿伐替尼突破性療法認定，用於治療晚期SM，包括侵襲性SM的亞型，以及伴有相關血液腫瘤和肥大細胞白血病的SM，以及中度至重度惰性SM。
來源：醫谷
原標題：胃腸道間質瘤精準靶向藥泰時維®(阿伐替尼片)在中國台灣獲批
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