AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from the phase 3 trialpresented at the 2025 American Society of Clinical Oncology Annual Meeting and subsequently published in The New England Journal of Medicine.
In the trial, Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus a taxane, trastuzumab and pertuzumab (THP) (based on a hazard ratio of 0.56; 95% 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 six months before the diagnosis of advanced or metastatic disease.
Median progression-free survival (PFS) was 40.7 months with Enhertu in combination with pertuzumab compared to 26.9 months with THP as assessed by blinded independent central review (BICR).
The safety profile of Enhertu plus pertuzumab was consistent with the known profiles of each individual treatment with no new safety concerns identified.
Based on the results, Enhertu in combination with pertuzumab has been included in the ESMO clinical practice guidelines as a category IA first-line treatment option for patients with metastatic HER2-positive breast cancer, regardless of hormone receptor (HR) status.
