Enhertu wins EU approval for adjuvant HER2-positive early breast cancer

AstraZeneca and Daiichi Sankyo announced on October 27, 2026 that the European Commission approved Enhertu (trastuzumab deruxtecan) as adjuvant treatment for HER2-positive early breast cancer. The approval covers adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2-targeted treatment, as a monotherapy.¹ The companies said this is the first EU approval of Enhertu in the curative-intent early breast cancer setting.¹

The decision follows a positive opinion from the EMA's CHMP and is based on 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.¹ In that trial, Enhertu significantly reduced the risk of invasive disease recurrence or death by 53% (hazard ratio 0.47; 95% CI 0.34-0.66; p<0.0001) compared to trastuzumab emtansine (T-DM1).¹ The three-year IDFS rate was 92.4% (95% CI 89.7-94.4) for Enhertu versus 83.7% (95% CI 80.2-86.7) for T-DM1.¹ The safety profile of Enhertu was consistent with its known profile, with no new safety concerns identified.¹

DESTINY-Breast05 enrolled 1,635 patients in Asia, Europe, North America, Oceania and South America.¹ With this approval, Enhertu is now approved in more than 35 countries for this adjuvant indication based on the DESTINY-Breast05 trial.¹

On financial terms, AstraZeneca owes Daiichi Sankyo a $75 million milestone payment for the adjuvant HER2-positive early breast cancer indication, and sales of Enhertu in most EU territories are recognized by Daiichi Sankyo.¹ AstraZeneca and Daiichi Sankyo entered their global collaboration to jointly develop and commercialize Enhertu in March 2019, excluding Japan, where Daiichi Sankyo retains exclusive rights.¹