AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo have secured their tenth Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration for ENHERTU, marking a pivotal step in moving the blockbuster treatment into earlier, potentially curative stages of breast cancer.
The latest regulatory milestone focuses on adult patients with HER2-positive early breast cancer who still have residual invasive disease following neoadjuvant treatment, a group at high risk of their cancer returning.
The FDA's decision was bolstered by data from the DESTINY-Breast05 Phase 3 trial, which was featured prominently at the 2025 European Society of Medical Oncology Congress and published in The New England Journal of Medicine.
The study demonstrated that ENHERTU, a specifically engineered antibody-drug conjugate (ADC), significantly outperformed the current standard of care in preventing the recurrence of invasive disease.
By targeting the post-neoadjuvant setting, the partners aim to intervene at a critical window before the disease can progress to a metastatic, or incurable, state.
Executives from both companies emphasized that the designation reflects the "transformational" nature of the drug’s clinical data.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, noted that the post-neoadjuvant setting represents a vital opportunity to improve long-term outcomes for patients who do not achieve a full response to initial therapy.
This latest recognition brings the total number of BTDs for ENHERTU to ten—six of which are in breast cancer alone—underscoring its dominance in the HER2-directed landscape.
The news comes as the joint venture continues to aggressively push ENHERTU into broader oncology applications.
In addition to the post-surgery setting, the FDA is currently reviewing an application for ENHERTU as a neoadjuvant treatment prior to surgery, based on the DESTINY-Breast11 trial.
As Daiichi Sankyo and AstraZeneca work toward a formal regulatory filing for this latest indication, the drug remains a cornerstone of their respective oncology portfolios, with sixteen total BTDs now held across Daiichi Sankyo’s broader pipeline.