WILMINGTON, Del., May 15, 2026
AstraZeneca and Daiichi Sankyo have announced that the U.S. Food and Drug Administration (FDA) approved Enhertu (trastuzumab deruxtecan) for two new indications in patients with HER2-positive early breast cancer, significantly expanding the use of the blockbuster antibody-drug conjugate into earlier stages of disease with curative intent. The approvals cover both the neoadjuvant (pre-surgery) and adjuvant (post-surgery) settings and are based on positive Phase III results from the DESTINY-Breast11 and DESTINY-Breast05 clinical trials.
The latest FDA decision marks a major milestone for Enhertu and strengthens its position as one of the most important therapies in modern oncology. Analysts believe the approvals could reshape the treatment landscape for patients with aggressive HER2-positive breast cancer while significantly expanding the commercial reach of the medicine in the early-stage setting.
FDA Approvals Expand Enhertu Into Curative-Intent Treatment
Under the new approvals, Enhertu followed by THP therapy (taxane, trastuzumab and pertuzumab) can now be used before surgery in adults with Stage II or Stage III HER2-positive breast cancer. In addition, Enhertu was approved after surgery for patients with residual invasive disease following trastuzumab-based and taxane-based treatment.
In the DESTINY-Breast11 Phase III trial, Enhertu demonstrated a pathologic complete response (pCR) rate of 67.3%, compared with 56.3% for the current standard chemotherapy regimen, representing a statistically significant improvement. Researchers noted that achieving pCR is strongly associated with improved long-term survival outcomes in early breast cancer.
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The DESTINY-Breast05 trial further strengthened the case for Enhertu in the adjuvant setting by showing the therapy reduced the risk of invasive disease recurrence or death by 53% compared to trastuzumab emtansine (T-DM1). After three years, 92.4% of patients treated with Enhertu remained alive and free of invasive disease versus 83.7% in the comparator group.
Clinical Data Reinforce Enhertu’s Leadership in HER2 Breast Cancer
Experts believe the approvals could redefine the standard of care for high-risk HER2-positive breast cancer patients. HER2-positive breast cancer accounts for approximately 20% of all breast cancer cases and is typically associated with aggressive disease progression and higher recurrence risk.
According to AstraZeneca, up to one in four patients with HER2-positive early breast cancer may still experience disease recurrence despite currently available treatments, highlighting the ongoing need for more effective therapeutic options.
The therapy’s safety profile remained generally consistent with previous studies, although cases of interstitial lung disease (ILD)/pneumonitis continued to require close monitoring. In the DESTINY-Breast05 study, most ILD cases were low grade, though two treatment-related deaths were reported in the Enhertu treatment arm.
The U.S. regulatory submissions for both indications were reviewed under Project Orbis, an international FDA-led oncology review collaboration framework designed to accelerate patient access to innovative cancer therapies globally.
Enhertu Continues Global Oncology Expansion
Enhertu has rapidly become one of the most successful antibody-drug conjugates in oncology, with approvals spanning metastatic and early-stage breast cancer, non-small cell lung cancer, gastric cancer, and HER2-positive solid tumors in more than 95 countries worldwide.
The therapy was jointly developed and commercialized by AstraZeneca and Daiichi Sankyo using Daiichi Sankyo’s proprietary DXd ADC technology, a platform that continues to drive next-generation oncology innovation. Following the new FDA approvals, AstraZeneca will pay Daiichi Sankyo $155 million in milestone payments tied to the two indications.
Industry experts view the approvals as a major advancement in precision oncology and a critical step toward improving long-term cure rates in early HER2-positive breast cancer patients worldwide.
Source: AstraZeneca, Daiichi Sankyo press release
