British-Swedish biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (NYSE:AZN) and Japanese healthcare company Daiichi Sankyo Co Ltd (TYO:4568) announced on Monday that Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union as an adjuvant monotherapy for adults with resected HER2-positive breast cancer who have residual invasive disease following neoadjuvant taxane-based and HER2-targeted treatment.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the Phase III DESTINY-Breast05 trial, presented at the 2025 European Society for Medical Oncology Congress and subsequently published in The New England Journal of Medicine.

In the trial, Enhertu reduced the risk of invasive disease recurrence or death by 53% versus trastuzumab emtansine (T-DM1). At three years, 92.4% of patients receiving Enhertu were alive and free of invasive disease, compared with 83.7% of patients receiving T-DM1.

The safety profile was consistent with the established profile of Enhertu, with no new safety concerns identified.

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised with AstraZeneca.

Enhertu is already approved in the US and other countries for the adjuvant treatment of patients with HER2-positive breast cancer with residual invasive disease following neoadjuvant treatment, based on DESTINY-Breast05.