British-Swedish biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) and Japanese healthcare company Daiichi Sankyo Co Ltd (TYO:4568) announced on Monday that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to a supplemental Biologics License Application (sBLA) for Enhertu (fam-trastuzumab deruxtecan-nxki) as a post-neoadjuvant treatment for adults with HER2-positive early breast cancer who have residual invasive disease after prior HER2-targeted therapy.

The sBLA is based on results from the Phase III DESTINY-Breast05 trial. In the study, Enhertu reduced the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine (T-DM1) and achieved a three-year invasive disease-free survival rate of 92.4% versus 83.7%. The therapy also reduced the risk of disease recurrence or death by 53% and lowered the risk of distant recurrence by 51% and brain metastases by 36%.

Safety results were consistent with the drug's established profile with no new safety concerns reported. The application is also under review through Project Orbis, with additional regulatory submissions underway in the EU and Japan.

The FDA's decision date under the Prescription Drug User Fee Act is expected in the third quarter of 2026.