百濟神州(06160.HK)和EUSA Pharma宣佈國家藥監局批准凱澤百®用於治療高危神經母細胞瘤患者
格隆匯8月18日丨百濟神州(06160.HK)發佈公吿，百濟神州於2021年8月17日(美國東部時間)和EUSA Pharma共同宣佈，中國國家藥品監督管理局(NMPA)已批准凱澤百®(達妥昔單抗β)用於治療12月齡及以上的高危神經母細胞瘤患者，這些患者既往接受誘導化療後至少達到部分緩解，且隨後進行過清髓性治療和幹細胞移植治療，也可用於伴或不伴有殘留病灶的復發或難治性(R/R)神經母細胞瘤患者。凱澤百®是一項已經獲得歐洲藥品管理局(EMA)批准上市的靶向免疫療法。
百濟神州總裁、首席運營官兼中國區總經理吳曉濱博士表示：“凱澤百®是一款對於中國兒童腫瘤患者意義重大的生物療法，現已被NMPA列入首批臨牀急需境外新藥名單。我們很榮幸能夠為中國的神經母細胞瘤患兒帶來首款獲批的靶向免疫療法。”
EUSA Pharma首席執行官Carsten Thiel博士表示：“我們很高興地看到凱澤百®的治療獲益在中國得到認可。此次獲批是我們與百濟神州合作的重要里程碑，也體現了我們致力於為患者帶來治療癌症和罕見病的創新藥物的決心。”
凱澤百®此次在中國獲批用於治療高危神經母細胞瘤患者，是基於國際兒科腫瘤協會歐洲神經母細胞瘤小組(SIOPEN)與APERION Biologics和EUSA Pharma合作開展的關鍵性試驗的臨牀結果。在這些試驗中評估了凱澤百®治療高危神經母細胞瘤的療效，其中包括一組對比凱澤百®單藥或聯合白介素–2(IL-2)作為一線療法的隨機對照試驗，以及兩項針對復發或難治性患者的單臂試驗。在SIOPEN試驗(HRNBL1)中，接受凱澤百®治療的患者的5年無事件生存率(EFS)為57%，歷史對照值為42%(p<0.01)，5年總生存率(OS)對照數據為64%對比50%(p≤0.0001)ii。凱澤百®治療的安全性是基於在514例患者中的評估，最常見的不良反應為發熱和疼痛，患者接受鎮痛治療後仍會發生。其他常見的不良反應為超敏反應、嘔吐、腹瀉、毛細血管滲漏綜合徵和低血壓。
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