Shots:
- China’s National Medical Products Administration has accepted the BLA for DualityBio’s trastuzumab pamirtecan (T-Pam; DB-1303/BNT323), an investigational ADC, for the second-line treatment of unresectable or metastatic HER2+ breast cancer
- The application is supported by interim results from the pivotal P-III (DB-1303-O-3001) trial, which met its primary endpoint, demonstrating statistically significant improvement in PFS vs trastuzumab emtansine (T-DM1)
- Trastuzumab pamirtecan is a next-generation HER2-targeted topoisomerase-1 inhibitor–based ADC, being developed by BioNTech and DualityBio; the program has also received US FDA Fast Track and Breakthrough Therapy Designations for endometrial cancer
Ref: DualityBio | Image: DualityBio | Press Release
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