The Food and Drug Administration has granted Priority Review to ENHERTU (fam-trastuzumab deruxtecan-nxki) for treating adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment, according to a statement from AstraZeneca (NYSE: AZN) and Daiichi Sankyo.

The FDA action date is anticipated during the third quarter of 2026. ENHERTU previously received Breakthrough Therapy Designation from the FDA for this indication.

The supplemental Biologics License Application is based on data from the DESTINY-Breast05 Phase III trial, which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine (T-DM1). The trial demonstrated a three-year invasive disease-free survival rate of 92.4% with ENHERTU compared to 83.7% with T-DM1.

Approximately one in five breast cancers are HER2-positive, a subtype often associated with aggressive disease. Around half of patients with HER2-positive early breast cancer have residual disease following neoadjuvant treatment, putting them at increased risk of disease recurrence.

The application is being reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. Regulatory submissions based on DESTINY-Breast05 are also under review in the European Union and Japan.

ENHERTU is currently approved in more than 90 countries as a treatment for patients with HER2-positive metastatic breast cancer. The drug is a HER2-directed antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.