Company: AZN
Filing Date: 2025-12-22
Form Type: 6-K
Source: 0001654954-25-014166
Chunk: 1

Company: ASTRAZENECA PLC
Filing Date: 2025-12-22
Form: 6-K
Chunk 1
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 Food and Drug Administration (FDA) BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.

The FDA granted this BTD based on results from the DESTINY-Breast05 Phase III trial presented in a Presidential Symposium at the 2025 European Society for Medical Oncology (ESMO) Congress and subsequently published 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, evaluating patients with high-risk HER2-positive disease in the neoadjuvant setting, is currently under review by the FDA.

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

#### Notes
**Post-neoadjuvant Treatment for HER2-Positive Early Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 1 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally. 1

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast cancer. 2 HER2 protein overexpression may