Home Daiichi Sankyo’s Enhertu (Trastuzumab Deruxtecan) Combined with Pertuzumab Receives CDE Acceptance for First-Line Treatment of HER2-Positive Metastatic Breast Cancer in China

Daiichi Sankyo’s Enhertu (Trastuzumab Deruxtecan) Combined with Pertuzumab Receives CDE Acceptance for First-Line Treatment of HER2-Positive Metastatic Breast Cancer in China

Nov 05, 2025 09:52 CST Updated 09:52
Daiichi-Sankyo

Pharmaceutical R&D Developer

News on November 5: The drug marketing application for Daiichi Sankyo's Enhertu (Trastuzumab Deruxtecan for Injection, DS-8201a, T-DXd, 100mg/vial) has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The proposed indication is for first-line treatment in combination with Pertuzumab for adult patients with unresectable or metastatic HER2-positive breast cancer. This marks the eighth indication for which Enhertu has submitted a marketing application in China, and the fifth breast cancer indication submitted in the country.