AstraZeneca and Daiichi’s Enhertu wins first-in-decade US oncology approval

The US Food and Drug Administration (FDA) has approved Enhertu (fam-trastuzumab deruxtecan-nxki) in combination with Perjeta (pertuzumab) as the first new first-line treatment in ten years for HER2-positive metastatic breast cancer.

Authorisation of the HER2-directed antibody drug conjugate (ADC) plus the monoclonal antibody is based on the results of the DESTINY-Breast09 phase III trial.

Enhertu is being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo, through a collaboration initiated in 2020.

The data for the drug’s latest approval were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.

In the phase III trial, Enhertu plus Perjeta reduced the risk of disease progression or death by 44 percent versus a taxane, trastuzumab and pertuzumab (THP) as a first-line treatment for this disease subtype.

Furthermore, median progression-free survival was 40.7 months with Enhertu plus Perjeta compared to 26.9 months for trastuzumab and pertuzumab.

Dr Sara Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and principal investigator for the trial, said: “Trastuzumab deruxtecan plus pertuzumab is the only [first]-line treatment approved in more than a decade to demonstrate a statistically significant improvement in progression-free survival over the current standard regimen for patients with HER2-positive metastatic breast cancer.

“With a median progression-free survival exceeding three years, versus approximately two years with [trastuzumab and pertuzumab (THP)], trastuzumab deruxtecan combined with pertuzumab should become a new [first]-line standard of care in this setting.”

Improving patient outcomes in metastatic breast cancer

Dave Fredrickson, Executive Vice President for AstraZeneca’s Oncology Haematology Business Unit, said: “With this approval, we are bringing Enhertu to the earliest setting for HER2-positive metastatic breast cancer, where optimising efficacy has an important impact on long-term outcomes. The treatment approach with Enhertu plus pertuzumab in DESTINY-Breast09 sets a new benchmark of more than three years without disease progression or death for patients in this setting.”

In October, AstraZeneca and Daiichi’s Datroway (datopotamab deruxtecan) became the first oncology drug to significantly improve overall survival compared to chemotherapy in metastatic triple-negative breast cancer (TNBC).