LONDON (dpa-AFX) - AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) Enhertu (trastuzumab deruxtecan) has been approved in the European Union as a treatment for adults with advanced breast cancer. It is for patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low, or HER2-ultralow breast cancer, who have already tried at least one endocrine therapy but are no longer suitable for more endocrine therapy.
The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the DESTINY-Breast06 Phase III trial. The results showed Enhertu demonstrated superiority compared to chemotherapy with a median progression-free survival of more than one year.
Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
Enhertu was approved in the US earlier this year based on the DESTINY-Breast06 results. Regulatory applications are under review in Japan and several other countries for this indication.
Enhertu is already approved in more than 75 countries, including the European Union, for patients with HER2-low metastatic breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.
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