AstraZeneca's Enhertu sBLA Gets FDA Priority Tag for Expanded Use

AstraZeneca (AZN) and partner Daiichi Sankyo announced that the FDA has accepted the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu for HER2-low metastatic breast cancer.The companies are seeking approval for Enhertu to treat unresectable or metastatic HER2-low or HER2-ultralow breast cancer in adult patients who have received at least one endocrine therapy in the metastatic setting.The sBLA looks to expand the currently approved indication of Enhertu in HER2- ...