AstraZeneca and Daiichi Sankyo’s Enhertu sBLA for HER2-Positive Breast Cancer Granted FDA Priority Review

A supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) from AstraZeneca and Daiichi Sankyo has been accepted for review by the U.S. Food and Drug Administration and granted Priority Review for the treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant HER2-targeted therapy.

Under Priority Review, the FDA shortens the standard review timeline for therapies that may provide significant improvements in safety or efficacy compared with available treatments. The agency has set a Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2026 to determine whether to approve the application.

Enhertu has also received Breakthrough Therapy Designation from the FDA for this treatment setting. The designation is intended to accelerate the development and regulatory review of investigational medicines that may address serious conditions and unmet medical needs. The application is also being evaluated under Project Orbis, which allows concurrent review of oncology medicines by multiple international regulatory authorities.

The submission is supported by data from the DESTINY-Breast05 Phase 3 trial (NCT04622319), which evaluated Enhertu as a post-neoadjuvant treatment in patients with HER2-positive early breast cancer who had residual disease after pre-surgical therapy.

In the study, Enhertu significantly reduced the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine (T-DM1). The trial reported a three-year invasive disease-free survival (IDFS) rate of 92.4% with Enhertu versus 83.7% with T-DM1, with results consistent across predefined patient subgroups. The therapy also reduced the risk of distant disease recurrence and brain metastases, while maintaining a safety profile consistent with previous studies.

Susan Galbraith, Executive Vice President, Oncology Hematology R&D, AstraZeneca said the FDA’s Priority Review marks an important step toward expanding the use of Enhertu for patients with HER2-positive early breast cancer who face a high risk of recurrence after initial therapy, potentially improving long-term outcomes.

Ken Takeshita Global Head, R&D, Daiichi Sankyo emphasized that additional treatment options are needed for patients with residual disease after neoadjuvant therapy, noting that the Priority Review highlights Enhertu’s potential to become a new standard of care based on results from the DESTINY-Breast05 trial.

Enhertu is a HER2-directed antibody-drug conjugate (ADC) developed using Daiichi Sankyo’s DXd technology and is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. The therapy is currently approved in more than 90 countries for certain patients with HER2-positive metastatic breast cancer.

Regulatory reviews based on the DESTINY-Breast05 results are also ongoing in Europe and Japan.

 Reference

Enhertu granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer, 09 March 2026, Enhertu granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer

A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05), ClinicalTrials.gov ID NCT04622319, https://clinicaltrials.gov/study/NCT04622319

Loibl S et al, Trastuzumab Deruxtecan in Residual HER2-Positive Early Breast Cancer. N Engl J Med. 2026 Feb 26;394(9):845-857. Epub 2025 Dec 10. PMID: 41370739. https://doi.org/10.1056/nejmoa2514661