20 January 2021 - Approval based on the DESTINY-Breast01 Phase 2 trial which showed clinically meaningful and durable responses in patients with previously treated disease.
Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) has been granted conditional approval in the European Union 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.