Posted by Michael Wonder on 22 Dec 2025
Enhertu granted breakthrough therapy designation in the US as post-neo-adjuvant therapy for patients with HER2 positive early breast cancer
22 December 2025 - Tenth breakthrough therapy designation for Daiichi Sankyo and AstraZeneca’s Enhertu with the latest based on DESTINY-Breast05 phase 3 trial results.
Enhertu (trastuzumab deruxtecan) has been granted breakthrough therapy designation 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 neo-adjuvant treatment and high risk of disease recurrence.
