EU approves Enhertu as adjuvant therapy for HER2‑positive early breast cancer
AstraZeneca and Daiichi Sankyo received European Commission approval for Enhertu (trastuzumab deruxtecan) as a post‑surgical adjuvant treatment for patients with HER2‑positive early breast cancer who have residual invasive disease after neoadjuvant therapy. The decision is based on the DESTINY‑Breast05 phase‑3 trial, which showed a 53% reduction in invasive disease recurrence or death versus T‑DM1. AstraZeneca will pay Daiichi Sankyo a $75 million milestone for the indication.
Why it matters
The approval opens a new market for Enhertu in the EU, potentially increasing AstraZeneca’s and Daiichi Sankyo’s sales in the HER2‑positive early‑breast‑cancer segment (the company notes the milestone payment).
Key facts
- 1EU approval was granted based on DESTINY‑Breast05 phase‑3 trial results showing a 53% reduction in invasive disease recurrence or death versus T‑DM1 (hazard ratio 0.47). finanznachrichten.de
- 2The trial reported a three‑year invasive disease‑free survival rate of 92.4% for Enhertu compared with 83.7% for T‑DM1. finanznachrichten.de
- 3AstraZeneca will pay Daiichi Sankyo $75 million as a milestone for the adjuvant HER2‑positive early breast cancer indication. finanznachrichten.de
- 4This is the first EU approval of Enhertu in the curative‑intent early breast cancer setting and the third EU approval for the drug within four months. stocktitan.net
- 5Enhertu is already approved in more than 35 countries/regions for the adjuvant treatment of HER2‑positive breast cancer. stocktitan.net
- 6AstraZeneca shares were down 0.35% in pre‑market trading following the announcement. rttnews.com
Summary written by AlphAI AI Desk from 6 of 6 sources. Not investment advice. Figures are as stated by the linked sources.