科伦药业核心产品芦康沙妥珠单抗(sac-TMT)获批第三项适应症

Core Viewpoint - Kelong Pharmaceutical's subsidiary Sichuan Kelong Botai Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) sac-TMT (also known as SKB264/MK-2870) for a new indication in treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment [1] Group 1 - The approved indication for sac-TMT is specifically for EGFR gene mutation-positive patients who have progressed after TKI treatment [1] - Sac-TMT is the first and only ADC globally to show significant overall survival (OS) benefits compared to platinum-based doublet chemotherapy [1] - In predefined OS analysis, sac-TMT demonstrated statistically and clinically significant improvements in progression-free survival and overall survival compared to the current standard of care [1]