Enhertu gains EU approval for HER2-low metastatic breast cancer
The European Commission has approved AstraZeneca and Daiichi Sankyo's Enhertu for a new patient population. The approval expands its use as a HER2-directed therapy for metastatic breast cancer.
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has received European Commission approval as a monotherapy for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer. This approval applies to patients who have undergone at least one prior endocrine therapy in the metastatic setting and are not suitable for further endocrine treatment.
The decision follows positive data from the DESTINY-Breast06 Phase III trial. The trial demonstrated that Enhertu provided a progression-free survival (PFS) of more than one year compared to chemotherapy in patients with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer. These findings were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.
HR-positive, HER2-negative breast cancer represents the most common subtype. While classified as HER2-negative, these tumors can still exhibit some level of HER2 expression. Historically, treatment for HR-positive metastatic breast cancer has relied on endocrine therapies, with subsequent chemotherapy often yielding poorer outcomes.
Enhertu is a HER2-directed antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. The drug received a similar approval in the US earlier this year based on the DESTINY-Breast06 results, and regulatory applications are under review in Japan and other countries.