信達生物(01801.HK):NMPA批准達伯舒®(信迪利單抗注射液)用於治療一線鱗狀非小細胞肺癌
格隆匯6月3日丨信達生物(01801.HK)發佈公吿,PD-1抑制劑達伯舒®(信迪利單抗注射液)正式獲得國家藥品監督管理局(“NMPA”)就其新適應症申請(“sNDA”)的批准,聯合吉西他濱和鉑類化療適用於不可手術切除的局部晚期或轉移性鱗狀非小細胞肺癌(“NSCLC”)的一線治療。
這是達伯舒®(信迪利單抗注射液)繼2018年12月獲得NMPA批准用於治療復發或難治性經典型霍奇金淋巴瘤、2021年2月獲得NMPA批准聯合培美曲塞和鉑類用於晚期非鱗狀NSCLC的一線治療後,所獲批的第三項適應症。這也是全球首個獲批的用於鱗狀NSCLC一線治療的免疫聯合吉西他濱和鉑類化療的方案。
此次適應症獲批是基於一項隨機、雙盲、III期對照臨牀(ORIENT-12)的研究結果——達伯舒®(信迪利單抗注射液)或安慰劑聯合健擇®(注射用吉西他濱)和鉑類化療用於一線治療晚期或轉移性鱗狀NSCLC。
肺癌是中國目前發病率和死亡率(約25%)均排名第一的惡性腫瘤。在所有肺癌中,非小細胞肺癌(NSCLC)大約佔80%至85%,約70%的NSCLC患者在確診時已無法手術切除,在根治性手術的I-III期的NSCLC患者中也有30-60%最終發生復發或遠處轉移。近二十年來,NSCLC的藥物研發進展主要集中在非鱗狀NSCLC,鱗狀NSCLC因其獨特的流行病學、組織病理學和分子生物學特徵,藥物研發相對緩慢。ORIENT-12研究顯示,信迪利單抗注射液聯合注射用吉西他濱和鉑類化療一線治療晚期或轉移性鱗狀NSCLC,顯着延長了無進展生存期(PFS);OS數據尚未成熟,但信迪利單抗聯合組較化療組總生存有獲益趨勢。
公司相信達伯舒®(信迪利單抗注射液)新適應症的獲批,為晚期肺鱗癌患者的一線治療提供了新的選擇,將使得更多患者獲益。
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