FDA Expands Label of AZN's Enhertu for New Breast Cancer Indication

AstraZeneca (AZN) and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab deruxtecan) for HER2-low metastatic breast cancer in the United States. The approval of the added indication has triggered a $175 million milestone payment from AstraZeneca to Daiichi Sankyo.The companies’ sBLA was seeking approval for Enhertu to treat unresectable or metastatic HR-positive, HER2-low or HER2-ultralow ...