Biopharmaceutical company AstraZeneca plc (LSE: AZN; Nasdaq: AZN), together with Daiichi Sankyo, announced on Monday that Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation by the US Food and Drug Administration for use as a post-neoadjuvant treatment in adults with HER2-positive early breast cancer with residual invasive disease and a high risk of recurrence.

Designation was based on Phase III DESTINY-Breast05 trial results, presented at the 2025 European Society for Medical Oncology Congress and subsequently published in The New England Journal of Medicine. The trial demonstrated superior outcomes versus trastuzumab emtansine in patients with residual disease following neoadjuvant therapy.

This approval marks the tenth Breakthrough Therapy Designation for Enhertu across multiple tumour settings and the second positive early breast cancer trial for the medicine in 2025. A separate Phase III study, DESTINY-Breast11, evaluating Enhertu in the neoadjuvant setting, is currently under FDA review.

Enhertu is a HER2-directed antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialised with AstraZeneca. The product is already approved in multiple HER2-driven cancers across more than 90 countries, supporting AstraZeneca's strategy to expand use of its antibody drug conjugate platform into earlier stages of disease.