Merck (MRK, Financial) announced that the U.S. FDA has granted Breakthrough Therapy Designation to its investigational antibody-drug conjugate (ADC), sacituzumab tirumotecan (Sac-TMT). This designation is for the treatment of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations, after progression on tyrosine kinase inhibitors (TKI) and platinum-based chemotherapy.
Sac-TMT, developed in collaboration with Kelun-Biotech (06990), targets TROP2, a protein highly expressed in various epithelial tumors. It combines a TROP2-targeting monoclonal antibody, a topoisomerase I inhibitor cytotoxic payload, and a novel hydrolyzable linker. The drug was initially developed by Kelun-Biotech and recently approved in China for treating certain breast cancers.
