Enhertu received EU approval as adjuvant treatment for HER2-positive early Breast cancer

CAR-T Digest - August 2020

Weekly Digest - October 2026

27 October 2026: Enhertu received EU approval as adjuvant treatment for HER2-positive early Breast cancer

Daiichi Sankyo and AstraZeneca announced that Enhertu has been approved in the European Union as an adjuvant treatment for adults with resected HER2-positive early breast cancer who have residual invasive disease following neoadjuvant taxane-based and HER2-targeted therapy. This marks Enhertu’s first EU approval in the curative-intent early breast cancer setting
The approval is based on the phase 3 DESTINY-Breast05 trial, where Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 (HR = 0.47; p < 0.0001), with three-year invasive disease-free survival rates of 92.4% versus 83.7%
The approval addresses an unmet need in high-risk HER2-positive early breast cancer, where patients with residual invasive disease after neoadjuvant treatment remain at increased risk of recurrence despite further adjuvant therapy
Enhertu is a HER2-directed ADC comprising a monoclonal antibody linked to multiple DXd topoisomerase I inhibitor payloads through cleavable tetrapeptide-based linkers. Its tumor-agnostic approach enables targeted cytotoxic delivery to HER2-overexpressing tumor cells across different tissue origins
Strategically, the EU approval moves Enhertu into the adjuvant, curative-intent setting, expanding its use earlier in HER2-positive breast cancer. It is the product’s third EU approval in four months and strengthens Daiichi Sankyo and AstraZeneca’s position in high-risk early breast cancer, with a $75 million milestone payment due from AstraZeneca to Daiichi Sankyo