AstraZeneca and Daiichi Sankyo’s Enhertu was granted BTD due to Destiny-Breast05 Phase III trial results
AstraZeneca and Daiichi Sankyo’s Enhertu has received Breakthrough Therapy Designation (BTD) in the US for adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes following neoadjuvant treatment and high risk of disease recurrence.
The Food and Drug Administration (FDA) BTD accelerates the development and regulatory review of potential new medicines for the treatment of a serious condition and to address an unmet medical need.
The FDA granted this BTD based on results from the Destiny-Breat05 Phase III trial, presented in a Presidential Symposium at the 2025 European Society for Medical Oncology Congress, before publication in The New England Journal of Medicine.
Susan Galbraith, executive vice president, Oncology Haematology R&D, AstraZeneca, said, “For patients with residual disease after neoadjuvant treatment, the post-neoadjuvant setting represents a critical opportunity to reduce the risk of recurrence and prevent progression to metastatic disease. This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care and underscores its potential to become an important treatment option in the post-neoadjuvant setting.”
Ken Takeshita, global head, R&D, Daiichi Sankyo, said, “This tenth Breakthrough Therapy Designation reinforces how Enhertu continues to deliver transformational results that advance the treatment of breast cancer. We look forward to working with the FDA with the goal of bringing Enhertu to the post-neoadjuvant setting of HER2-positive early breast cancer, as DESTINY-Breast05 clearly demonstrated that Enhertu may help halt invasive disease recurrence over the current standard of care, resulting in potentially more patients achieving a cure.”
DESTINY-Breast05 is the second positive trial of Enhertu in early breast cancer in 2025. The first trial, DESTINY-Breast11, evaluated patients with high-risk HER2-positive disease in the neoadjuvant setting and is currently under review by the FDA.
Enhertu is a specifically engineered HER2-directed DXd antibody-drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
