智通财经APP获悉，默沙东公司(MRK.US)今日宣布，美国FDA已授予在研抗体偶联药物(ADC)sacituzumab tirumotecan(Sac-TMT)突破性疗法认定，用于治疗携带表皮生长因子受体(EGFR)突变的晚期或转移性非鳞状非小细胞肺癌(NSCLC)患者，这些患者的疾病在接受酪氨酸激酶抑制剂(TKI)和含铂化疗后出现进展。Sac-TMT是默沙东与科伦博泰(06990)合作开发的TROP2靶向在研ADC。新闻稿指出，这是该疗法首次获得美国FDA授予的突破性疗法认定。
Sac-TMT由靶向TROP2的单克隆抗体sacituzumab、拓扑异构酶1抑制剂类别的细胞毒性载荷，和一种新型、可水解的连接子组合而成。TROP2在多种上皮来源的肿瘤中高表达，可促进肿瘤细胞增殖、侵袭及转移。Sac-TMT最初由科伦博泰开发，最近已获得中国国家药品监督管理局(NMPA)批准上市，用于治疗不可切除的局部晚期或转移性三阴性乳腺癌(TNBC)成人患者，这些患者至少接受过两种全身治疗(其中至少一种针对晚期或转移阶段疾病)。此前默沙东与科伦博泰达成合作协议，科伦博泰授予默沙东在大中华区以外地区开发、生产及商业化Sac-TMT的独家权利。
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