Fourth NDA for Kelun-Biotech’s TROP2 ADC Sacituzumab tirumotecan (sac-TMT) accepted by the Center for Drug Evaluation

CAR-T Digest - August 2020

22 May 2025: Fourth NDA for Kelun-Biotech’s TROP2 ADC Sacituzumab tirumotecan (sac-TMT) accepted by the Center for Drug Evaluation

The NMPA’s Center for Drug Evaluation (CDE) accepted a new application for sac-TMT to treat unresectable, locally advanced or metastatic HR+/HER2- breast cancer in adults who have received prior therapies
The Phase 3 OptiTROP-Breast02 trial demonstrated that sac-TMT significantly enhanced progression-free survival versus physician-selected chemotherapy, supporting the application
In addition to improved PFS, sac-TMT showed a positive trend for overall survival (OS), with ongoing evaluation during extended follow-up
This is the fourth sac-TMT indication accepted for priority review by the CDE, with three previous indications having been approved through this expedited process
Kelun-Biotech emphasized plans to further develop sac-TMT across additional cancer indications with unmet medical needs, reinforcing its commitment to global cancer care innovation