百濟神州(688235.SH)：國家藥監局批准百澤安®用於治療微衞星高度不穩定型或錯配修復基因缺陷型實體瘤患者
格隆匯3月11日丨百濟神州(688235.SH)公佈，公司近日獲悉國家藥品監督管理局(“國家藥監局”)已附條件批准公司核心產品百澤安®(替雷利珠單抗注射液)用於治療不可切除或轉移性微衞星高度不穩定型(MSI-H)或錯配修復基因缺陷型(dMMR)成人晚期實體瘤患者。
已於中國境內獲批適應症：完全批准百澤安®聯合化療用於治療一線晚期鱗狀非小細胞肺癌(NSCLC)患者、百澤安®聯合化療用於治療一線晚期非鱗狀NSCLC患者以及百澤安®用於治療既往接受含鉑化療後出現疾病進展的二線或三線局部晚期或轉移性 NSCLC 患者。附條件批準百澤安®用於治療至少經過二線系統化療的復發或難治性經典型霍奇金淋巴瘤患者、PD-L1 高表達的含鉑化療失敗包括新輔助或輔助化療 12個月內進展的局部晚期或轉移性尿路上皮癌患者、至少經過一種全身治療的肝細胞癌患者以及用於治療不可切除或轉移性微衞星高度不穩定型(MSI-H)或錯配修復基因缺陷型(dMMR)成人晚期實體瘤患者(包括既往接受過氟尿嘧啶類、奧沙利鉑和伊立替康治療後出現疾病進展的晚期結直腸癌患者以及既往治療後出現疾病進展且無滿意替代治療方案的其他晚期實體瘤患者)。針對上述附條件獲批適應症的完全批准將取決於確證性臨牀試驗結果。
百澤安®的此次獲批是基於一項單臂、多中心、開放性、關鍵性 2期臨牀試驗(NCT03736889)的結果，該試驗旨在評估百澤安®單藥治療既往經治、局部晚期不可切除或轉移性 MSI-H 或 dMMR 實體瘤患者的有效性和安全性。
此次獲批是百澤安®在中國獲得的第七項新適應症批准，有望進一步提升該藥物的可及性。百澤安®擁有廣泛的全球臨牀開發項目，包括13項3期試驗和4項關鍵性2期試驗，該等試驗正在為其有效性和安全性提供越來越多的臨牀證據，並在多種癌症類型中確立其治療的影響力。
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