Core Viewpoint - The company Kolon Biotech has received breakthrough therapy designation from the NMPA for its antibody-drug conjugate sac-TMT in combination with the PD-L1 monoclonal antibody for the treatment of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without driver gene mutations, indicating significant clinical advantages over existing treatments [1][2]. Group 1 - The breakthrough therapy designation aims to expedite the research, development, and promotion of innovative treatments to address urgent medical needs [1]. - This marks the fifth breakthrough therapy designation for sac-TMT, with previous recognitions for treating various cancers including triple-negative breast cancer (TNBC) and hormone receptor-positive breast cancer [2]. - The results of the phase 2 OptiTROP-Lung01 clinical study for sac-TMT combined with Tagoli monoclonal antibody in treating advanced or metastatic non-squamous NSCLC patients will be presented at the 2025 ASCO annual meeting [2].
科伦博泰生物-B(06990.HK)：核心产品TROP2ADC芦康沙妥珠单抗(SAC-TMT)联合PD-L1单抗塔戈利单抗一线治疗无驱动基因突变的局部晚期或转移性非鳞状非小细胞肺癌获国家药监局突破性疗法认定