Shots:
- The EMA has validated the Type II Variation MAA for Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the 1L treatment of patients with HER2+ positive unresectable or metastatic breast cancer.
- MAA was supported by P-III (DESTINY-Breast09) trial data on Enhertu (5.4mg/kg) ± Perjeta vs taxane, trastuzumab & Perjeta (THP) in HER2+ metastatic breast cancer pts (n=1157), data were presented at ASCO’25 and subsequently published in THE NEJM
- Enhertu is a HER2-directed ADC built on Daiichi Sankyo’s DXd technology, comprising a HER2 mAb linked via cleavable tetrapeptide linkers to a topoisomerase I inhibitor payload (DXd), and is being jointly developed & commercialized by Daiichi Sankyo & AstraZeneca
Ref: Daiichi Sankyo | Image: Daiichi Sankyo | Press Release
Related News: Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINY-Endometrial02) Trial of Enhertu for HER2+ Endometrial Cancer
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