AstraZeneca, Daiichi Sankyo’s Enhertu Gets New US Approval for Two HER2-Positive Breast Cancer Indications

AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) gained U.S. FDA approval for two new indications for patients with breast cancer.

Namely, the indications cover the neoadjuvant and adjuvant treatments of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. The FDA’s approval was based on results from two Phase III trials (DESTINY-Breast11 and DESTINY-Breast05, respectively).

Previous Actions on Enhertu

Earlier in 2026, the FDA in March granted Priority Review to the supplemental Biologics License Application (sBLA) based on DESTINY-Breast05.

In the neoadjuvant setting, Enhertu can precede taxane, trastuzumab, and pertuzumab (THP) for HER2-positive Stage II or III breast cancer. For the adjuvant setting, it is approved for patients with residual invasive disease after trastuzumab (with/without pertuzumab) and taxane-based treatment.

AstraZeneca Says ‘Important Step Forward’

Shanu Modi, MD, Medical Oncologist at Memorial Sloan Kettering Cancer Center, said both the neoadjuvant and adjuvant settings have advantages.

“Our goal is to reduce the risk of recurrence for patients as early as possible,” Modi said. “These two new indications in HER2-positive early breast cancer will evolve how we treat patients in these settings.”

According to Dave Frederickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca, clinicians consider HER2-positive early disease “highly curable.”

“However, up to 1 in 4 patients still experience disease recurrence, underscoring the need for new options in this setting,” Frederickson said. “These approvals mark an important step forward, expanding the possibility of cure to more patients.”

Daiichi Sankyo to Receive $155M

Neither the DESTINY-Breast11 nor DESTINY-Breast05 trials identified any new safety concerns with Enhertu.

Enhertu is approved in nearly 100 countries for treatment of patients with HER2-positive metastatic breast cancer. With these new approvals, AstraZeneca will award $155 million to Daiichi Sankyo, which originally discovered Enhertu, as milestone payments.