EU Approves Enhertu for Adjuvant Treatment of HER2-Positive Breast Cancer
The European Commission approved AstraZeneca and Daiichi Sankyo's Enhertu for patients with residual disease after surgery. Reported by Reuters.
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what happened
The European Commission has approved Enhertu (trastuzumab deruxtecan) as a monotherapy for adult patients with HER2-positive breast cancer and residual invasive disease after neoadjuvant treatment. The decision is based on Phase III data from the DESTINY-Breast05 trial. AstraZeneca and Daiichi Sankyo announced the approval in a press release, which Reuters distributed.
In the trial, the drug cut the risk of recurrence or death by 53% compared with T-DM1. The three-year invasive disease-free survival rate was 92.4%, versus 83.7% for T-DM1. Following the approval, AstraZeneca owes Daiichi Sankyo a milestone payment of $75 million.
why it matters
The EU approval extends the drug's use to an earlier stage of care, where patients receive treatment after surgery. The $75 million milestone is modest for AstraZeneca, so the impact on its financial results is limited, and the news has little relevance for the broader market.
market impact
AstraZeneca and Daiichi Sankyo: the expanded EU indication supports Enhertu's sales outlook
tags
instruments
sources
- REG - AstraZeneca PLC - Enhertu approved in EU for HER2-positive eBC — Reuters, 27 October 2026 at 07:30 UTC
- Astrazeneca's Enhertu Approved In EU For HER2-Positive eBC — Reuters, 27 October 2026 at 07:33 UTC
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