Global pharma giants AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has secured Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration for adult patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant therapy and face a high risk of recurrence.

 

The FDA’s BTD accelerates the development and review of promising new treatments for serious conditions with significant unmet medical needs.

 

The designation follows results from the DESTINY-Breast05 Phase III trial, presented in a Presidential Symposium at the 2025 European Society for Medical Oncology (ESMO) Congress and published in The New England Journal of Medicine.

 

Susan Galbraith, Executive Vice President of Oncology Haematology R&D at 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 of R&D at Daiichi Sankyo, added: “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 marks the second positive trial of Enhertu in early breast cancer this year. The first, DESTINY-Breast11, targeting high-risk HER2-positive patients in the neoadjuvant setting, is currently under FDA review.