Enhertu has been approved in the EU as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer.
The drug is approved as monotherapy for adult patients who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
Enhertu is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.
“The European approval of Enhertu in the HER2 low metastatic breast cancer population marks the first time we will have the opportunity to treat patients with lower levels of HER2 expression with a HER2 directed therapy,” said Javier Cortés, Head, International Breast Cancer Center (IBCC), Barcelona, Spain. “Enhertu has shown a significant improvement in outcomes compared to chemotherapy for these patients, reinforcing its potential to become a new standard of care.”
The European Commission approval is based on the DESTINY-Breast04 trial results where Enhertu reduced the risk of disease progression or death by 50% and increased median overall survival by more than six months versus chemotherapy.
“Historically, patients with breast cancer who have tumors with low levels of HER2 expression have been classified as HER2 negative, giving them limited treatment options beyond chemotherapy,” added Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca. “This approval reinforces the important role Enhertu may have for patients with HER2 low disease and highlights the need to evolve the way breast cancer is treated to improve outcomes for patients.”