EU Expands Approval of AstraZeneca and Daiichi Sankyo’s Enhertu

The EU has expanded its approval of AstraZeneca and Daiichi Sankyo’s oncology drug Enhertu (trastuzumab deruxtecan) to include patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received one or more prior anti-HER2-based regimens.

Previously, the EU only authorized the drug after two or more HER2-targeted treatments.

The expanded approval followed a positive opinion from the EMA’s Committee for Medicinal Products for Human Use and positive results from a phase 3 study in which Enhertu reduced the risk of disease progression or death by 72 percent compared with trastuzumab emtansine.

An antibody drug conjugate, Enhertu is approved in more than 30 countries, including the U.S. The drug is currently under review in Europe for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.