AstraZeneca and Daiichi Sankyo’s Enhertu Receives Breakthrough Therapy Designation for Early HER2-Positive Breast Cancer
Tuesday, December 23, 2025
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) for use as a post-neoadjuvant treatment in adults with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant therapy and are at high risk of recurrence.
Enhertu is a HER2-directed antibody-drug conjugate discovered by Daiichi Sankyo and is being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. The therapy has shown potential to improve outcomes across multiple stages of HER2-positive breast cancer.
DESTINY-Breast05 represents the second positive early breast cancer study for Enhertu reported in 2025. Earlier this year, the Phase III DESTINY-Breast11 trial, which evaluated Enhertu in patients with high-risk HER2-positive disease in the neoadjuvant setting, also reported positive results and is currently under FDA review.
The FDA’s Breakthrough Therapy Designation is intended to speed up the development and review of medicines that aim to treat serious conditions and address significant unmet medical needs.
The designation was based on results from the Phase III DESTINY-Breast05 trial. The study findings were presented during a Presidential Symposium at the 2025 European Society for Medical Oncology (ESMO) Congress and later published in The New England Journal of Medicine. The trial demonstrated that Enhertu showed superior clinical benefit compared with the current standard of care in reducing the risk of invasive disease recurrence in this patient population.
This designation supports closer interaction with the FDA and may help accelerate patient access to promising therapies.
Source: astrazeneca.com
