Enhertu granted breakthrough therapy designation in the US as post-neoadjuvant therapy for patients with HER2-positive early breast cancer

CAR-T Digest - August 2020

Weekly Digest - December 2025

22 December 2025: Enhertu granted breakthrough therapy designation in the US as post-neoadjuvant therapy for patients with HER2-positive early breast cancer

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received its tenth FDA Breakthrough Therapy Designation, this time for adults with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant treatment and are at high risk of recurrence
The designation is based on positive results from the Phase 3 DESTINY-Breast05 trial, which were presented at the 2025 ESMO Congress and later published in The New England Journal of Medicine
FDA Breakthrough Therapy Designation is intended to speed development and regulatory review of therapies that address serious conditions with significant unmet medical need, highlighting Enhertu’s strong clinical benefit over the current standard of care
Leaders from AstraZeneca and Daiichi Sankyo emphasized that the post-neoadjuvant setting is a critical window to reduce recurrence and prevent progression to metastatic disease, with DESTINY-Breast05 showing Enhertu may better halt invasive disease recurrence
DESTINY-Breast05 marks the second positive early breast cancer trial for Enhertu in 2025, following DESTINY-Breast11 in the neoadjuvant setting, which is currently under FDA review, reinforcing Enhertu’s expanding role across stages of HER2-positive breast cancer