China’s National Medical Products Administration has accepted a biologics license application for trastuzumab pamirtecan (T-Pam; DB-1303), moving it closer to becoming a new second-line treatment for HER2-positive metastatic breast cancer.
The application is based on a Phase 3 trial comparing T-Pam with Kadcyla. The study showed that T-Pam significantly improved progression-free survival. It also demonstrated activity in HER2-low cancers, suggesting it could benefit a broader group of patients, while maintaining a manageable safety profile.
T-Pam is a next-generation antibody-drug conjugate designed to precisely target cancer cells. It binds to HER2 receptors, enters the tumor cell, and releases a chemotherapy payload that damages DNA and stops cancer growth.
Beyond China, T-Pam is gaining global attention. The U.S. Food and Drug Administration granted it Breakthrough Therapy Designation in 2023 for advanced endometrial cancer. Ongoing Phase 3 trials are also exploring its use in breast and endometrial cancers across different HER2 expression levels.