智通财经APP讯，科伦博泰生物-B(06990)发布公告，公司靶向人滋养细胞表面抗原2(TROP2)的抗体药物偶联物(ADC)芦康沙妥珠单抗(sac-TMT，前称SKB264/MK-2870)(佳泰莱®)获国家药品监督管理局(NMPA)批准第二个适应症，用于治疗经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)和含铂化疗治疗后进展的EGFR基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌(NSCLC)成人患者。这是全球首个在肺癌适应症获批上市的TROP2ADC药物。与目前标准治疗相比，芦康沙妥珠单抗(sac-TMT)显著延长此类患者的总生存获益。
本次批准是基于一项多中心、随机、对照关键临床研究(OptiTROP-Lung03)，评估芦康沙妥珠单抗(sac-TMT)单一疗法每两周(Q2W)5mg/kg静脉注射对比多西他赛用于治疗经EGFR-TKI和含铂化疗治疗(序贯或联合)失败后的局部晚期或转移性EGFR突变NSCLC患者的有效性和安全性。在预设的期中分析结果显示，与多西他赛相比，芦康沙妥珠单抗(sac-TMT)单一疗法在客观缓释率(ORR)、无进展生存期(PFS)和总生存期(OS)方面具有显著统计学意义和临床意义的改善。
此前，NMPA已批准芦康沙妥珠单抗(sac-TMT)用于治疗既往至少接受过2种系统治疗(其中至少1种治疗针对晚期或转移性阶段)的不可切除的局部晚期或转移性三阴性乳腺癌;并已受理一项芦康沙妥珠单抗(sac-TMT)单药治疗经EGFR-TKI治疗失败的EGFR突变NSCLC患者的补充新药申请(sNDA)。
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