ASTRAZENECA PLC (AZN) Form 6-K — Oct 27, 2026
The European Commission has approved Enhertu (trastuzumab deruxtecan) in the EU as adjuvant monotherapy for patients with resected HER2-positive early breast cancer who have residual invasive disease after neoadjuvant therapy. The approval is the first EU approval of Enhertu in a curative-intent early breast cancer setting and is based on the Phase III DESTINY-Breast05 trial, which showed a 53% reduction in the risk of invasive disease recurrence or death versus T-DM1 (hazard ratio 0.47), with a three-year invasive disease-free survival rate of 92.4% versus 83.7%.
Key figures
- Trial enrollment
- 1635
- Idfs hazard ratio
- 0.47
- Milestone payment due usd
- $75 million
- Countries approved adjuvant
- more than 35
- Idfs risk reduction percent
- 53
- Three year idfs tdm1 percent
- 83.7
- Three year idfs enhertu percent
- 92.4
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