AstraZeneca and its Japanese partner Daiichi Sankyo have won European Union approval for the breast cancer drug Enhertu as a treatment given after surgery to patients with HER2-positive early disease.
The approval from the European Commission covers adults whose tumours were removed but who still had residual invasive disease after earlier treatment with a taxane (a type of chemotherapy) and HER2-targeted therapy. HER2 is a growth-promoting protein found on the surface of some breast cancer cells.
It is the first EU approval of Enhertu in early breast cancer, where the aim is cure rather than controlling advanced disease.
The decision rests on the DESTINY-Breast05 Phase III trial of 1,635 patients, which compared Enhertu with trastuzumab emtansine (T-DM1), the previous standard of care in this setting.
Enhertu cut the risk of invasive disease recurrence or death by 53%. The three-year rate of patients free of invasive disease was 92.4%, against 83.7% for T-DM1. The safety profile was in line with what is already known, with no new concerns.
The results were presented at the 2025 European Society for Medical Oncology Congress and later published in The New England Journal of Medicine.
Dave Fredrickson, AstraZeneca's head of oncology haematology, said the approval "has the potential to establish a new benchmark" in this setting.
Enhertu is an antibody drug conjugate, a medicine that links a cancer-targeting antibody to a chemotherapy payload. Daiichi Sankyo discovered it and the two companies develop and sell it jointly.
The approval triggers a $75m milestone payment from AstraZeneca to Daiichi Sankyo. Daiichi Sankyo books Enhertu sales in most EU territories.
The drug is already approved for this use in more than 35 countries.
