10 Mar 2025: Kelun-Biotech’s TROP2 ADC Sacituzumab Tirumotecan (sac-TMT) approved for marketing in second indication by NMPA for EGFRm NSCLC
• Sichuan Kelun-Biotech’s TROP2-directed ADC, sac-TMT, is now approved in China for EGFR-mutant NSCLC after EGFR-TKI and platinum-based chemotherapy
• Sac-TMT is the first TROP2-targeted ADC approved worldwide for lung cancer, showing significant OS benefits
• The approval is based on the OptiTROP-Lung03 study, where sac-TMT outperformed docetaxel in ORR, PFS, and OS
• Sac-TMT was earlier approved in China for advanced TNBC after at least two prior systemic treatments
• Kelun-Biotech and MSD are conducting global Phase 3 trials, including sac-TMT with osimertinib for first-line EGFR-mutant NSCLC
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