ENHERTU receives priority review for HER2-positive early breast cancer

Go back to ENHERTU receives priority review for HER2-positive early breast cancer

ENHERTU® (fam-trastuzumab deruxtecan-nxki) granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer

March 9, 2026 7:00 AM EDT

Based on DESTINY-Breast05 Phase III trial results which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared with T-DM1

If approved, AstraZeneca and Daiichi Sankyos ENHERTU has the potential to become a new standard of care in this early breast cancer setting

WILMINGTON, Del.--(BUSINESS WIRE)-- AstraZeneca and Daiichi Sankyos supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the US for the treatment of adult patients with HER2-positive breast cancer... More