AstraZeneca's (AZN) sBLA for Enhertu Gets FDA's Priority Tag

AstraZeneca (AZN) announced that the FDA has granted priority review to a supplemental biologics license application (sBLA) seeking approval for the expanded use of Enhertu (trastuzumab deruxtecan) to treat unresectable or metastatic HER2-positive solid tumors in heavily-pretreated patients. A filing designated as a priority review reduces the review period by four months. A final decision is expected during the second quarter of 2024.Enhertu, a specifically engineered HER2-directed antibody-drug conjugate ...