AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast09 phase 3 trial presented at the 2025 American Society of Clinical Oncology Annual Meeting and subsequently published in The New England Journal of Medicine.

Susan Galbraith, Executive Vice President (EVP), Oncology Haematology R&D, AstraZeneca, said, “HER2-positive metastatic breast cancer is an aggressive subtype, so starting patients on an effective HER2-targeted treatment early and continuing it for as long as they benefit can have a meaningful impact on long-term outcomes. DESTINY-Breast09 sets a new benchmark with a median Progression-Free Survival (PFS) of more than 3 years, underscoring the potential of Enhertu plus pertuzumab to redefine first-line treatment for patients with HER2-positive metastatic breast cancer.”

In DESTINY-Breast09, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44 percent versus a taxane, trastuzumab and pertuzumab (THP) (based on a hazard ratio of 0.56; 95 percent Confidence Interval [CI]: 0.44-0.71; p<0.00001) in patients with HER2-positive metastatic breast cancer who had not received prior chemotherapy or HER2-targeted therapy or had received neoadjuvant or adjuvant HER2-targeted therapy more than 6 months before the diagnosis of advanced or metastatic disease. Median PFS was 40.7 months with Enhertu in combination with pertuzumab compared to 26.9 months with THP. The PFS benefit was consistent across subgroups, including for the prespecified stratification factors of hormone receptor status, de novo or recurrent disease and PIK3CA mutation status.

John Tsai, Global Head, Research and Development (R&D), Daiichi Sankyo, said, “Enhertu in combination with pertuzumab improved Progression-Free Survival by more than 1 year compared with the current first-line Standard of Care (SoC), representing a meaningful advantage early in the treatment of patients with metastatic HER2-positive disease. Today’s positive CHMP opinion brings us closer to making Enhertu available in the EU as a first-line treatment option for eligible patients with HER2-positive metastatic breast cancer, marking an important milestone in moving this medicine earlier in the treatment pathway.”

The safety profile of Enhertu plus pertuzumab was consistent with the known profiles of each individual therapy with no new safety concerns identified.

Enhertu in combination with pertuzumab is approved in the US, Switzerland and other countries as a first-line treatment for patients with metastatic HER2-positive breast cancer based on the results from the DESTINY-Breast09 trial.

Enhertu is also under review in the EU for patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment based on data from the DESTINY-Breast05 trial.

Enhertu is a specifically engineered HER2-directed DXd Antibody Drug Conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.