Trastuzumab deruxtecan granted FDA Priority Review
17 Oct 2019 07:00 BST Trastuzumab deruxtecan granted FDA Priority Review fortreatment of patients with HER2-positive metastatic breast cancer AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) date for trastuzumab deruxtecan, a HER2-targeting antibody drug conjugate (ADC) and potential new medicine for the treatment of HER2-