AstraZeneca and Daiichi Sankyo have announced that the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted for review by the US Food and Drug Administration (FDA) and granted Priority Review status.

The application seeks approval for Enhertu as a treatment for adult patients with HER2-positive breast cancer who have residual invasive disease after receiving neoadjuvant HER2-targeted therapy prior to surgery. The FDA grants Priority Review to therapies that may offer significant improvements in safety or effectiveness compared with current treatment options. The agency’s decision is expected during the third quarter of 2026 under the Prescription Drug User Fee Act timeline.

Enhertu was also recently granted Breakthrough Therapy Designation by the FDA for this treatment setting, a status intended to accelerate the development and review of medicines targeting serious conditions with significant unmet medical needs. The application is additionally being evaluated through Project Orbis, an international initiative that allows concurrent regulatory review of oncology medicines across participating global health authorities.

HER2-positive breast cancer accounts for around one in five breast cancer cases and is often associated with aggressive disease and a higher risk of recurrence. Despite treatment with neoadjuvant therapy before surgery, approximately half of patients continue to have residual disease, increasing the likelihood of cancer recurrence or progression to metastatic disease.

The sBLA submission is based on results from the Phase III DESTINY-Breast05 trial, which compared Enhertu with trastuzumab emtansine (T-DM1) as post-neoadjuvant therapy in patients with HER2-positive early breast cancer at high risk of recurrence. Findings from the study were presented at the European Society for Medical Oncology Congress 2025 and later published in the The New England Journal of Medicine.

In the trial, Enhertu significantly reduced the risk of invasive disease recurrence or death by 53 percent compared with T-DM1. The therapy achieved a three-year invasive disease-free survival rate of 92.4 percent, compared with 83.7 percent for patients treated with T-DM1. The study also demonstrated significant reductions in disease recurrence, distant metastases and brain metastases risk.

The safety profile observed in the DESTINY-Breast05 trial was consistent with the known safety profile of Enhertu and no new safety concerns were identified.

Enhertu is an antibody-drug conjugate targeting the HER2 protein and was discovered by Daiichi Sankyo using its proprietary DXd antibody-drug conjugate technology. The therapy is being jointly developed and commercialised globally by AstraZeneca and Daiichi Sankyo.

Currently, Enhertu is approved in more than 90 countries for treating patients with HER2-positive metastatic breast cancer and is also being evaluated across several other HER2-targetable cancers and earlier treatment settings.

Breast cancer remains one of the most common cancers worldwide, with more than two million cases diagnosed annually. HER2-positive disease represents a particularly aggressive subtype, making advancements in targeted therapies critical to improving patient outcomes.