AstraZeneca and Daiichi Sankyo Expand ENHERTU Use in Early HER2-Positive Breast Cancer in the US
Tuesday, May 19, 2026
AstraZeneca and Daiichi Sankyo have received approval from the US Food and Drug Administration for the use of Enhertu (trastuzumab deruxtecan) in both neoadjuvant and adjuvant treatment settings for patients with HER2-positive early breast cancer.
The approval is based on findings from the Phase III DESTINY-Breast11 and DESTINY-Breast05 clinical trials. In the neoadjuvant setting, Enhertu followed by taxane, trastuzumab and pertuzumab (THP) is approved for adults with HER2-positive Stage II or Stage III breast cancer. In the adjuvant setting, the drug is approved for adults with HER2-positive breast cancer who have residual invasive disease after trastuzumab-based and taxane-based treatment.
The companies stated that the approvals strengthen the role of Enhertu as a treatment option in early-stage HER2-positive breast cancer and may help reduce the risk of disease recurrence.
In DESTINY-Breast05, Enhertu reduced the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine (T-DM1) in patients with residual invasive disease after neoadjuvant therapy. After three years, 92.4% of patients treated with Enhertu remained free of invasive disease compared with 83.7% in the T-DM1 group. These results were published in The New England Journal of Medicine.
Following the DESTINY-Breast05 findings, Enhertu was added to the NCCN Clinical Practice Guidelines in Oncology as a Category 1 recommended adjuvant treatment for patients with HER2-positive early breast cancer who are at high risk of recurrence after preoperative therapy.
No new safety concerns were reported in either study. In DESTINY-Breast11, Enhertu followed by THP showed similar rates of adverse events and interstitial lung disease compared with standard treatment, while severe adverse events and blood-related toxicities were lower.
In DESTINY-Breast05, overall adverse event rates were similar between Enhertu and T-DM1. However, interstitial lung disease or pneumonitis occurred more frequently in the Enhertu group. Most cases were low grade, although there were seven Grade 3 events and two treatment-related deaths.
The regulatory submissions for both studies were reviewed under Project Orbis, an international programme designed to support simultaneous review of oncology medicines across multiple countries. Separate regulatory reviews are also ongoing in other regions.
Enhertu is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. The HER2-directed antibody drug conjugate is already approved in more than 95 countries for several HER2-positive and HER2-low cancers, including metastatic breast cancer, gastric cancer and non-small cell lung cancer.
Following the latest approvals in the US, AstraZeneca will pay Daiichi Sankyo milestone payments worth US$155 million under the companies’ collaboration agreement signed in 2019.
Source: astrazeneca.com
