The US FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for HER2-positive early breast cancer, extending its use into both pre- and post-surgical settings. 

 

The nod also reinforces its growing role in potentially curative treatment strategies.

 

The approvals are based on results from two Phase III trials—DESTINY-Breast11 and DESTINY-Breast05—and cover use in the neoadjuvant (before surgery) and adjuvant (after surgery) settings.

 

In the neoadjuvant setting, Enhertu followed by a taxane, trastuzumab, and pertuzumab (THP) is now approved for adults with HER2-positive Stage II or Stage III disease. In the adjuvant setting, it is approved for patients with residual invasive disease after standard trastuzumab-based therapy and taxane chemotherapy.

 

Commenting on the significance of the approvals, Shanu Modi, Medical Oncologist at Memorial Sloan Kettering Cancer Center, said:

"HER2-positive breast cancer is an aggressive disease, and our goal is to reduce the risk of recurrence for patients as early as possible to achieve the best long-term outcomes. 

 

"The neoadjuvant setting offers the earliest opportunity to improve outcomes, while the adjuvant setting provides another important chance to prevent recurrence for patients with residual disease after surgery. These two new indications in HER2-positive early breast cancer will evolve how we treat patients in these settings and support trastuzumab deruxtecan as a potential new standard of care in early-stage disease.”

 

AstraZeneca highlighted the move as a major step toward earlier intervention in curable disease.

 

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "HER2-positive early disease is considered highly curable, however up to one in four patients still experience disease recurrence, underscoring the need for new options in this setting. 

 

"These approvals mark an important step forward, expanding the possibility of cure to more patients for the first time in many years and positioning Enhertu as a foundational treatment in early breast cancer.”

 

Daiichi Sankyo also pointed to the broader transformation of HER2-targeted therapy across disease stages.

 

Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. said: "Enhertu has redefined the treatment of HER2-expressing breast cancer with practice-changing data across six breast cancer indications in seven years. 

 

"Enhertu is now approved in the US across both early and metastatic HER2-positive breast cancer, accomplishing what we set out to achieve a little over a decade ago for patients at the start of our comprehensive clinical development programme.”

 

Patient advocacy groups also welcomed the development, highlighting its potential to reduce progression to advanced disease.

 

Victoria Smart, Senior Vice President, Mission, Susan G. Komen, said: "Providing patients with early breast cancer more options to help prevent progression to metastatic disease can lead to improved outcomes. Progression and recurrence remain among the most significant unmet needs for those diagnosed with early breast cancer, and continued advances in treatment bring new hope to patients and families facing this disease.”

 

In DESTINY-Breast11, the Enhertu-based regimen achieved a pathologic complete response (pCR) rate of 67.3%, compared with 56.3% for the standard ddAC-THP regimen, representing an 11.2% improvement.

 

In DESTINY-Breast05, Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 in patients with residual disease after surgery.