WILMINGTON, Del. — AstraZeneca and Daiichi Sankyo said the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to ENHERTU (fam-trastuzumab deruxtecan-nxki) as a post-neoadjuvant treatment for adult patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant therapy and face a high risk of recurrence.
The designation is the tenth Breakthrough Therapy Designation awarded to ENHERTU and is based on results from the DESTINY-Breast05 Phase III clinical trial. The data were presented in a Presidential Symposium at the 2025 European Society for Medical Oncology Congress and later published in The New England Journal of Medicine.
Breakthrough Therapy Designation is intended to accelerate the development and regulatory review of medicines that treat serious conditions and address significant unmet medical needs.
“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,” said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca. “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 of R&D at Daiichi Sankyo, said the latest designation further validates ENHERTU’s impact across breast cancer treatment settings.
“This tenth Breakthrough Therapy Designation reinforces how ENHERTU continues to deliver transformational results that advance the treatment of breast cancer,” Takeshita said. “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 marks the second positive ENHERTU trial in early breast cancer reported in 2025. Earlier this year, the DESTINY-Breast11 trial, which evaluated ENHERTU in patients with high-risk HER2-positive disease in the neoadjuvant setting, was submitted to the FDA and remains under regulatory review.
ENHERTU is a HER2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and is being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
