AstraZeneca (AZ) and Daiichi Sankyo's TROP2-targeting antibody-drug conjugate (ADC) datopotamab deruxtecan has received approval from China's National Medical Products Administration (NMPA) for HR-positive, HER2-negative metastatic breast cancer after endocrine therapy and chemotherapy failure. The approval was based on Phase III TROPION-Breast01 trial results showing a 37% reduction in progression risk versus chemotherapy, with median progression-free survival (mPFS) of 6.9 months versus 4.9 months. The ADC demonstrated a favourable safety profile with grade 3+ adverse events occurring in 21% of patients, half the rate seen with chemotherapy.

Datopotamab deruxtecan uses Daiichi's proprietary DXd platform to deliver a topoisomerase I inhibitor payload to tumours expressing TROP2, a protein prevalent in multiple solid tumours. The drug's approval establishes a new standard of care for pretreated HR+/HER2- breast cancer patients in China, with ongoing trials evaluating its potential in other indications including non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC).

According to PharmCube's NextBiopharm® database, among 87 TROP2 ADC active projects worldwide, only two other have been launched, namely Pfizer/Gilead's sacituzumab govitecan and MSD's sacituzumab tirumotecan. Click here to request a free trial for NextBiopharm®.