Business
Enhertu granted BTD for post-neoadjuvant early BC
AstraZeneca and Daiichi Sankyo's Enhertu has received Breakthrough Therapy Designation from the US FDA for HER2-positive early breast cancer patients with residual disease after neoadjuvant treatment, based on positive DESTINY-Breast05 Phase III trial results. This designation accelerates the development and review of Enhertu as a potential treatment option in this setting, aiming to reduce disease recurrence risk. This marks the tenth Breakthrough Therapy Designation for Enhertu, highlighting its potential to significantly improve outcomes for patients with high-risk early breast cancer. Disclaimer*
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\n22 December 2025\n \nEnhertu granted Breakthrough Therapy Designation in the US as post-neoadjuvant therapy for patients with HER2-positive early breast cancer\n \nTenth Breakthrough Therapy Designation for AstraZeneca and Daiichi Sankyo's Enhertu with the latest based on DESTINY-Breast05 Phase III trial results\n \nAstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been granted 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 after neoadjuvant treatment and high risk of disease recurrence.\n \nThe 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.\n \nThe 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.\n \nSusan 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.\"\n \nKen 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.\"\n \nDESTINY-Breast05 is the second positive trial of Enhertu in early breast cancer in 2025. The first trial, DESTINY-Br...