AstraZeneca and Daiichi Sankyo’s Enhertu Recommended for EU Approval in HR-Positive, HER2-Low Breast Cancer

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for HR-positive, HER2-low, or HER2-ultralow metastatic breast cancer following endocrine therapy. The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is based on results from the DESTINY-Breast06 Phase III trial, presented at ASCO 2024 and published in The New England Journal of Medicine.

The trial demonstrated a 38% reduction in disease progression or death with Enhertu compared to chemotherapy (HR 0.62; p<0.0001), with a median progression-free survival (PFS) of 13.2 months versus 8.1 months. These results were consistent across HER2-low and HER2-ultralow patients, highlighting the therapy’s potential to redefine breast cancer treatment.

Enhertu, a HER2-directed antibody-drug conjugate (ADC), has already been approved in the U.S. for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer following endocrine therapy. Regulatory reviews are ongoing in Japan and other countries.

Susan Galbraith, EVP of Oncology R&D at AstraZeneca, emphasized that Enhertu could become the first HER2-directed treatment for this patient population in the EU, shifting the treatment paradigm. Ken Takeshita, Global Head of R&D at Daiichi Sankyo, added that the CHMP recommendation supports a new approach to classifying and treating breast cancer.

If approved, Enhertu could provide a more effective alternative to chemotherapy, improving outcomes for patients with advanced breast cancer.