AstraZeneca's (LSE:AZN) Enhertu, developed with Japan's Daiichi Sankyo, has been recommended for approval in the European Union as an adjuvant treatment for adults with HER2-positive breast cancer who still have residual disease after surgery and pre-surgical treatment.
The Committee for Medicinal Products for Human Use based its opinion on the Phase III DESTINY-Breast05 trial, which found Enhertu cut the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine (T-DM1), the current EU standard of care for these patients.
At three years, 92.4% of patients on Enhertu remained alive and free of invasive disease, against 83.7% on T-DM1.
"Enhertu cut the risk of disease recurrence by more than half compared to adjuvant standard of care for patients with residual disease, and if approved could redefine post-surgery care in the EU", said Susan Galbraith, AstraZeneca's Executive Vice President of Oncology Haematology R&D.
Roughly one in five breast cancer cases is HER2-positive, and about a third of HER2-positive early-stage patients are classed as high-risk for recurrence.
Enhertu already holds approval for this adjuvant indication in the US, Brazil, India and Canada based on the same trial data.
The medicine, a HER2-directed antibody drug conjugate, is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo under a collaboration dating to March 2019.
A final European Commission decision on the EU marketing authorisation is expected to follow the CHMP's recommendation.
News Intelligence what this means for the company
The EU's medicines regulator recommended Enhertu for adjuvant use in HER2-positive early breast cancer with residual disease, based on a trial showing a 53% reduction in disease recurrence or death versus the current standard of care (T-DM1). The European Commission approved Enhertu with pertuzumab for first-line metastatic HER2-positive breast cancer on 1 September 2026, and this adjuvant recommendation extends the drug's reach into the post-surgery setting where roughly one in three HER2-positive early-stage patients face high recurrence risk.
Enhertu now has regulatory backing across both metastatic and adjuvant HER2-positive breast cancer in the EU, following earlier US, Brazilian, Indian and Canadian approvals for the adjuvant indication. The 53% reduction in recurrence or death versus T-DM1 and 92.4% three-year disease-free survival rate establish a clinically meaningful advantage that could reshape post-surgery treatment patterns in a patient population representing roughly one in five breast cancer cases.
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