Enhertu approved in EU for HER2-positive metastatic breast cancer
The European Commission has granted conditional approval for AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) for adult patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based regimens.
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has received conditional approval in the European Union (EU). The therapy is indicated for adult patients with unresectable or metastatic HER2-positive breast cancer, specifically for those who have undergone two or more prior anti-HER2-based treatment regimens. This marks a significant step in expanding treatment options for patients with advanced HER2-positive breast cancer in the region.
The European Commission's decision was based on the positive results from the DESTINY-Breast01 Phase II trial. This single-arm study demonstrated that Enhertu achieved clinically meaningful and durable anti-tumour activity in a patient population with previously treated HER2-positive metastatic breast cancer. The trial reported a confirmed objective response rate (ORR) of 61.4%, including a 6.5% complete response rate, with a median duration of response (DoR) estimated at 20.8 months.
Breast cancer is a prevalent disease in Europe, with approximately one in five cases being HER2-positive. This approval offers a new therapeutic avenue for patients with limited treatment options. The companies intend to further investigate Enhertu's potential in earlier lines of treatment and disease stages.
Safety data from clinical trials indicate that the most common adverse reactions associated with Enhertu include nausea, fatigue, vomiting, and anemia. Interstitial lung disease (ILD) or pneumonitis occurred in 15.0% of patients, leading to death in 2.6% of those cases. Further ongoing trials are evaluating Enhertu in various breast cancer settings.