Treatment of HER2-Positive Metastatic Breast Cancer Approved in the EU
AstraZeneca and Daiichi Sankyo Company, Limited’s Enhertu (trastuzumab deruxtecan) announced the conditional approval in the European Union (EU) on January 20, 2021, as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.
The European Commission's approval was based on positive results from the single-arm DESTINY-Breast01 Phase II trial. Enhertu showed clinically meaningful and durable antitumor activity in patients with HER2-positive metastatic breast cancer who had received two or more prior anti-HER2-based regimens.
The approval follows the December 2020 recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency, which reviewed the application under its accelerated assessment procedure.