Enhertu granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer

CAR-T Digest - August 2020

Weekly Digest - March 2026

9 March 2026: Enhertu granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer

AstraZeneca and Daiichi Sankyo announced that the U.S. FDA has accepted the supplemental Biologics License Application for Enhertu (trastuzumab deruxtecan) and granted Priority Review for its use as a post-neoadjuvant treatment in adult patients with HER2-positive early breast cancer who have residual invasive disease after prior HER2-targeted therapy
The application is supported by results from the Phase 3 DESTINY-Breast05 trial, where Enhertu significantly reduced the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine (T-DM1), demonstrating a meaningful improvement in invasive disease-free survival
In the study, Enhertu achieved a three-year invasive disease-free survival rate of 92.4% compared with 83.7% for T-DM1, while also reducing the risk of distant recurrence and brain metastases, reinforcing its potential to improve outcomes in patients at high risk of relapse after neoadjuvant therapy
The FDA’s Priority Review designation highlights the potential of Enhertu to offer significant clinical benefits over existing treatments, with a regulatory decision expected in the third quarter of 2026, while the submission is also being reviewed under Project Orbis to enable coordinated international regulatory assessments
If approved, Enhertu could become a new standard of care in the post-neoadjuvant setting for HER2-positive early breast cancer, expanding its role beyond metastatic disease and offering a promising strategy to reduce recurrence and progression to metastatic cancer