AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) received Priority Review in the U.S. from a supplemental Biologics License Application (sBLA).

The FDA granted the Priority Review for treatment of adults with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Specifically, the indication is for such patients who have residual invasive disease following neoadjuvant HER2-targeted treatment.

For this setting, Enhertu also received Breakthrough Therapy Designation (BTD) from the FDA in December 2025. The treatment’s sBLA is additionally under review by Project Orbis. These specifications help expedite regulatory reviews both domestically and internationally.

History and Future of Enhertu

Daiichi Sankyo first discovered Enhertu, now approved in almost 100 countries as a treatment for HER2-positive metastatic breast cancer. Together with AstraZeneca, Daiichi Sankyo then developed and commercialized the HER2-directed DXd antibody-drug conjugate.

The sBLA now subject to Priority Review was based on data from a Phase III trial (DESTINY-Breast05). These data were presented at the European Society for Medical Oncology (ESMO) 2025 Congress. The findings were then published in The New England Journal of Medicine.

Crucially, the data showed Enhertu significantly reduced risk of invasive disease recurrence or death, by 53%, versus trastuzumab emtansine. Invasive disease-free survival results proved consistent in all prespecified subgroups.

The treatment also reduced risk of disease recurrence or death, a key secondary endpoint, by the same percentage.

Other Review Locations and Dates

Further regulatory submissions for Enhertu, based on the DESTINY-Breast05 trial, are under review in the European Union and Japan. In the U.S., an sBLA for Enhertu followed by paclitaxel, trastuzumab, and pertuzumab is also being reviewed. This is for neoadjuvant treatment of patients with HER2-positive early breast cancer, and is based on results from DESTINY-Breast11.

The Prescription Drug User Fee Act date for a decision on the FDA’s Priority Review is due in Q3 2026.