Shots:
- FDA has granted priority review to Enhertu’s sBLA for adults with HER2+ breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment, with submission to be reviewed under Project Orbis (PDUFA: Q3’26); review is also ongoing in the EU & Japan
- sBLA was backed by the global P-III (DESTINY-Breast05) trial assessing Enhertu (5.4mg/kg) vs trastuzumab emtansine in 1,635 HER2+ early breast cancer pts
- Trial showed improved IDFS by 53%, with 3yr. IDFS rate of 92.4% vs 83.7%, plus Enhertu also improved DFS by 53%, while lowering the risk of distant disease recurrence by 51% & the risk of brain metastases by 36%; results were published in The NEJM
Ref: AstraZeneca | Image: AstraZeneca & Daiichi Sankyo |Press Release
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