Breakthrough Therapy Designation Granted in China for Sacituzumab Tirumotecan (sac-TMT) + Pembrolizumab for 1L PD-L1-Positive NSCLC
TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) in combination with anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA) was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have PD-L1 tumor proportion score (TPS)≥1% and are EGFR-negative and ALK-negative.
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