金吾财讯 | 科伦博泰生物（06990）发布公告，公司靶向人滋养细胞表面抗原2（TROP2）的抗体偶联药物（ADC）芦康沙妥珠单抗（sac-TMT，亦称SKB264/MK-2870）（佳泰莱®）的一项新增适应症上市申请已获中国国家药品监督管理局（NMPA）药品审评中心（CDE）受理，用于程序性细胞死亡配体1（PD-L1）综合阳性评分（CPS）＜10或早期阶段接受过程序性细胞死亡蛋白-1（PD-1）╱PD-L1抑制剂的复发或转移性三阴性乳腺癌（TNBC）的一线治疗。这是芦康沙妥珠单抗（sac-TMT）获NMPA受理的第六项适应症上市申请。
此前，芦康沙妥珠单抗（sac-TMT）用于一线治疗不可手术切除的局部晚期、复发或转移性PD-L1阴性TNBC已获NMPA授予突破性疗法认定（BTD）。本次新增适应症上市申请亦已纳入优先审评审批程序，成为芦康沙妥珠单抗（sac-TMT）纳入该程序的第六项上市申请。截至目前，芦康沙妥珠单抗（sac-TMT）的4项适应症已于中国获批上市。
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