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 expansion into the early-stage treatment of breast cancer.
The latest regulatory milestone focuses on adult patients with HER2-positive early breast cancer who exhibit residual invasive disease in the breast or lymph nodes following neoadjuvant treatment—a population currently facing a high risk of disease recurrence.
The FDA's decision was catalyzed by results from the pivotal DESTINY-Breast05 Phase III trial, which was presented during a Presidential Symposium at the 2025 European Society for Medical Oncology (ESMO) Congress and subsequently published in The New England Journal of Medicine.
The data highlighted ENHERTU’s ability to significantly improve outcomes for patients who do not achieve a full response to initial therapy, providing a potent alternative to the current standard of care in the post-neoadjuvant setting.
This designation underscores the rapid clinical momentum for the drug, which is a specifically engineered HER2-directed DXd antibody-drug conjugate (ADC).
DESTINY-Breast05 represents the second positive trial for ENHERTU in early breast cancer this year, following the DESTINY-Breast11 study.
While the latest designation focuses on post-surgical residual disease, the DESTINY-Breast11 trial—which evaluates the drug’s efficacy prior to surgery—is already under active review by the FDA.
Executives from both pharmaceutical giants emphasized the potential for ENHERTU to shift the paradigm of curative-intent treatment.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, noted that the post-neoadjuvant setting is a "critical opportunity" to prevent the progression to incurable metastatic disease.
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, added that the drug continues to deliver transformational results that could lead to more patients achieving a permanent cure.
As the partners work toward a formal supplemental Biologics License Application, ENHERTU remains a cornerstone of their joint oncology strategy, targeting a wide array of HER2-expressing solid tumors.