EU Recommends Approval of Dato-DXd for Advanced HR+ HER2- Breast Cancer

Datopotamab deruxtecan (Dato-DXd) has received a recommendation for approval in the European Union (EU) to treat adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have undergone endocrine therapy and at least one line of chemotherapy in the advanced stage.

Datopotamab deruxtecan is a specially designed TROP2-targeting DXd antibody-drug conjugate (ADC) identified by Daiichi Sankyo and is being collaboratively developed and marketed by Daiichi Sankyo and AstraZeneca.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) relied on findings from the TROPION-Breast01 phase 3 trial published in the Journal of Clinical Oncology to form its favorable opinion. The European Commission will now evaluate the recommendation, as it holds the power to provide marketing authorizations for medications in the EU.

“Disease progression after endocrine and initial chemotherapy is common in patients with metastatic HR positive, HER2 negative breast cancer,” said Ken Takeshita, MD, global head, R&D, Daiichi Sankyo. “This positive recommendation by the CHMP for datopotamab deruxtecan, which follows recent approvals in the US and Japan, underscores the potential of this TROP2 directed antibody drug conjugate to offer a new treatment option to patients in the EU with this type of breast cancer."