AstraZeneca, Daiichi Sankyo's Enhertu Recommended for EU Approval for HER2 Positive Breast Cancer

08:37 AM EDT, 09/18/2026 (MT Newswires) -- AstraZeneca (AZN) and Daiichi Sankyo's Enhertu has been recommended for approval in the European Union as a monotherapy for the adjuvant treatment of adults with resected HER2 positive breast cancer who have residual disease after neoadjuvant treatment, Daiichi Sankyo said Friday. The European Medicines Agency's Committee for Medicinal Products for Human Use based its recommendation on results from a phase 3 trial that showed Enhertu significantly reduced the risk of invasive disease recurrence or death by 53%, Daiichi Sankyo said. The European Commission will now review the recommendation to determine marketing authorization in the EU, the company added.