Enhertu approved in EU for HER2-positive eBC
AstraZeneca and Daiichi Sankyo received European Commission approval for Enhertu as adjuvant monotherapy for HER2-positive early breast cancer patients with residual invasive disease after neoadjuvant therapy. The approval is based on the DESTINY-Breast05 Phase III trial, in which Enhertu cut the risk of invasive disease recurrence or death by 53% versus T-DM1, with a three-year IDFS rate of 92.4% versus 83.7%. This is the first EU approval of Enhertu in a curative-intent early breast cancer setting, extending the ADC into earlier lines of treatment where patient volumes are larger.
Key figures
- Drug Name
- Enhertu (trastuzumab deruxtecan)
- Phase Of Trial
- Phase 3
- Trial enrollment
- 1635
- Idfs hazard ratio
- 0.47
- Idfs risk reduction
- 53%
- Three year idfs tdm1
- 83.7%
- Milestone payment due
- $75 million
- Three year idfs enhertu
- 92.4%
- Countries approved adjuvant
- more than 35
AI analysis
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