AstraZeneca’s Enhertu Snags EU Approval for Metastatic Breast Cancer

AstraZeneca and Daiichi Sankyo have announced that their drug Enhertu (trastuzumab deruxtecan) has received conditional approval in the European Union to treat adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens.

The approval was based on positive results from a phase 2 trial, in which Enhertu showed clinically meaningful anti-tumor activity in patients with HER2-positive metastatic breast cancer who had received two or more prior anti-HER2-based treatments.

The FDA granted Enhertu an Accelerated Approval for the same indication in December 2019.