基石藥業-B(02616.HK)舒格利單抗獲內地批准治療細胞淋巴瘤患者
基石藥業-B(02616.HK)公布,國家藥品監督管理局(NMPA)已批准PD-L1抗體舒格利單抗(擇捷美)用於治療復發或難治性結外NK/T細胞淋巴瘤(R/R ENKTL)患者。由此,舒格利單抗成為全球首個針對R/R ENKTL適應症獲批的腫瘤免疫治療藥物。
舒格利單抗是全球首個針對復發或難治性結外NK/T細胞淋巴瘤適應症獲批的抗PD-L1單克隆抗體藥物。GEMSTONE-201研究結果顯示,舒格利單抗在R/R ENKTL患者中具有優異的抗腫瘤活性、持久的腫瘤緩解和良好的安全性。
此外,舒格利單抗先後被美國食品藥品監督管理局(FDA)和國家藥品監督管理局(NMPA)授予突破性療法認定和納入突破性治療藥物,用於治療成人R/R ENKTL。
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