Accelerated Approval of AstraZeneca and Daiichi Sankyo’s Enhertu based on the DESTINY-Breast01 trial that showed clinically meaningful and durable responses
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has approved Enhertu (fam-trastuzumab deruxtecan-nxki) 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 in the metastatic setting.
This indication is approved under Accelerated Approval based on