科伦博泰生物-B(06990)核心产品TROP2 ADC芦康沙妥珠单抗(SAC-TMT)联合免疫疗法帕博利珠单抗一线治疗PD-L1阳性局部晚期或转移性非小细胞肺癌获NMPA突破性疗法认定

智通财经
Jan 05

智通财经APP讯,科伦博泰生物-B(06990)公布,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®)联合默沙东的抗程序性细胞死亡蛋白1(PD-1)单克隆抗体帕博利珠单抗(可瑞达®)一线治疗程序性细胞死亡配体1(PD-L1)肿瘤比例分数(TPS)≥1%的表皮生长因子受体(EGFR)基因突变阴性和间变性淋巴瘤激酶(ALK)阴性的局部晚期或转移性非小细胞肺癌(NSCLC),已获NMPA药品评审中心授予突破性疗法认定。

突破性疗法认定主要授予对于尚无有效治疗手段的,该药物可以提供有效防治手段或与现有治疗手段相比具有明显临床优势的治疗方案。对于纳入突破性治疗药物程序的药物,在符合相关条件的情况下,可以在申请药品上市许可时提出附条件批准申请和优先审评审批申请。

此前,公司公布了芦康沙妥珠单抗(sac-TMT)联合帕博利珠单抗一线治疗PD-L1阳性NSCLC的3期OptiTROP-Lung05临床试验结果,其在主要终点无进展生存期(PFS)显示出统计学意义和临床意义的显著改善,并在总生存期(OS)方面观察到获益趋势。OptiTROP-Lung05研究是首个免疫联合ADC在一线治疗NSCLC上达到主要终点的3期临床研究。此次在一线治疗PD-L1阳性NSCLC获得突破性疗法认定,将为加速芦康沙妥珠单抗(sac-TMT)在此适应症审评与上市进程提供助力。

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